Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Phase I and Randomized Phase II Double Blind Clinical Trial of Cisplatin and Etoposide in Combination With Veliparib (ABT-888) or Placebo as Frontline Therapy for Extensive Stage Small Cell Lung Cancer
5 other identifiers
interventional
156
1 country
428
Brief Summary
This randomized phase I/II trial studies the side effects and best dose of veliparib when given together with or without cisplatin and etoposide and to see how well they work in treating patients with extensive stage small cell lung cancer or large cell neuroendocrine non-small cell lung cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work better in treating patients with extensive stage small cell lung cancer or metastatic large cell neuroendocrine non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Sep 2012
Longer than P75 for phase_1
428 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
September 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2018
CompletedResults Posted
Study results publicly available
February 5, 2019
CompletedMay 6, 2023
May 1, 2023
4.2 years
July 13, 2012
September 7, 2018
May 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Recommended Phase II Dose (Phase I)
dose of veliparib which was deemed to be the recommended phase II dose to be administered in the combination with CE for the phase II clinical trial
assessed for a maximum of cycle 1
Progression Free Survival (Phase II)
Profession free survival (PFS) is defined as time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date they were last known to be alive and progression-free. Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, and progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Median PFS was estimated using the Kaplan-Meier method.
Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of first documented progression or death. No specific requirements if patient is > 3 years from registration
Secondary Outcomes (2)
Overall Survival (OS)
Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration until the date of death. No specific requirements if patient is > 3 years from registration
Overall Response Rate (ORR)
assessed every 6 weeks while on study, then every 3 months for patients < 2 years from registration and every 6 months if patient is 2- 3 years from registration.
Other Outcomes (1)
Neurotoxicity Total Score Change Between Baseline and 3 Months After Treatment Start
assessed at baseline and 3 months after treatment initiation
Study Arms (2)
Arm A (veliparib)
EXPERIMENTALPatients receive veliparib PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm B (placebo)
ACTIVE COMPARATORPatients receive placebo PO BID on days 1-7, etoposide IV over 60-120 minutes on days 1-3, and cisplatin IV over 60-120 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study
- All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
- Patients must have histologically or cytologically confirmed:
- Extensive stage small cell lung cancer (SCLC) or
- Stage IV (M1a or M1b according to American Joint Committee on Cancer \[AJCC\] Staging Manual, 7th edition) large cell neuroendocrine non-small cell lung cancer (NSCLC) or
- Small cell carcinoma of unknown primary or extrapulmonary origin and must be a candidate for systemic therapy
- NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
- Patients must have measurable or non-measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; baseline measurements and evaluations of all sites of disease must be obtained =\< 4 weeks prior to registration (Phase I)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelets \>= 100,000/mm\^3
- Leukocytes \>= 3,000/mm\^3
- Hemoglobin \>= 9 g/dL
- Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
- +8 more criteria
You may not qualify if:
- Patients have active seizure(s) or history of seizure(s)
- Patients have history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in the study
- PHASE II
- Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study
- All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) with the current month counted as month 1
- Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
- Patients must have extensive stage, histologically or cytologically confirmed small cell lung cancer; NOTE: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
- Patients must have measurable disease based on RECIST 1.1; baseline measurements and evaluations of all sites of disease must be obtained =\< 4 weeks prior to registration
- ECOG performance status 0 or 1
- Absolute neutrophil count \>= 1,500/mm\^3
- Platelets \>= 100,000/mm\^3
- Leukocytes \>= 3,000/mm\^3
- Hemoglobin \>= 9 g/dL
- Total bilirubin =\< 1.5 times institutional upper limit of normal (ULN)
- AST (SGOT) and ALT (SGPT) =\< 3 times institutional ULN (=\< 5 times if LFT elevations due to known liver metastases)
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (428)
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Stanford Cancer Institute Palo Alto
Palo Alto, California, 94304, United States
Rocky Mountain Cancer Centers-Aurora
Aurora, Colorado, 80012, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Rocky Mountain Cancer Centers-Boulder
Boulder, Colorado, 80304, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Midtown
Denver, Colorado, 80218, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, 80218, United States
Rocky Mountain Cancer Centers-Rose
Denver, Colorado, 80220, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program NCORP
Denver, Colorado, 80222, United States
Mercy Medical Center
Durango, Colorado, 81301, United States
Southwest Oncology PC
Durango, Colorado, 81301, United States
Comprehensive Cancer Care and Research Institute of Colorado LLC
Englewood, Colorado, 80113, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Mountain Blue Cancer Care Center
Golden, Colorado, 80401, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Rocky Mountain Cancer Centers-Greenwood Village
Greenwood Village, Colorado, 80111, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado, 80228, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Rocky Mountain Cancer Centers-Littleton
Littleton, Colorado, 80120, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Rocky Mountain Cancer Centers-Sky Ridge
Lone Tree, Colorado, 80124, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
Rocky Mountain Cancer Centers-Parker
Parker, Colorado, 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
Rocky Mountain Cancer Centers - Pueblo
Pueblo, Colorado, 81008, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado, 80260, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105, United States
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Hawaii Cancer Care Inc-POB II
Honolulu, Hawaii, 96813, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
Hawaii Cancer Care Inc-Liliha
Honolulu, Hawaii, 96817, United States
Hawaii Oncology Inc-Kuakini
Honolulu, Hawaii, 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Hawaii Oncology Inc-Pali Momi
‘Aiea, Hawaii, 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii, 96701, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii, 96701, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706, United States
Kootenai Cancer Center
Post Falls, Idaho, 83854, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Centralia Oncology Clinic
Centralia, Illinois, 62801, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Carle on Vermilion
Danville, Illinois, 61832, United States
Cancer Care Specialists of Central Illinois
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Carle Physician Group-Effingham
Effingham, Illinois, 62401, United States
Crossroads Cancer Center
Effingham, Illinois, 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, 60026, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, 60035, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, 60901, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
NorthShore Hematology Oncology-Libertyville
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, 61938, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, 61265, United States
Trinity Medical Center
Moline, Illinois, 61265, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois, 60451, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
SwedishAmerican Regional Cancer Center/ACT
Rockford, Illinois, 61114, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Cancer Care Specialists of Illinois-Swansea
Swansea, Illinois, 62226, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
The Carle Foundation Hospital
Urbana, Illinois, 61801, United States
Rush-Copley Healthcare Center
Yorkville, Illinois, 60560, United States
IU Health North Hospital
Carmel, Indiana, 46032, United States
Michiana Hematology Oncology PC-Crown Point
Crown Point, Indiana, 46307, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
IU Health Central Indiana Cancer Centers-East
Indianapolis, Indiana, 46219, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Woodland Cancer Care Center
Michigan City, Indiana, 46360, United States
Memorial Regional Cancer Center Day Road
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, 46563, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, 46391, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Genesis Medical Center - East Campus
Davenport, Iowa, 52803, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Oncology Hematology Care Inc-Crestview
Crestview Hills, Kentucky, 41017, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Lafayette Family Cancer Center-EMMC
Brewer, Maine, 04412, United States
Penobscot Bay Medical Center
Rockport, Maine, 04856, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, 21287, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106, United States
Beaumont Hospital-Dearborn
Dearborn, Michigan, 48124, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829, United States
Genesys Hurley Cancer Institute
Flint, Michigan, 48503, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Lake Huron Medical Center
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Sanford Clinic North-Bemidgi
Bemidji, Minnesota, 56601, United States
Essentia Health Saint Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, 56537, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Health Partners Inc
Minneapolis, Minnesota, 55454, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, 65613, United States
Parkland Health Center-Bonne Terre
Bonne Terre, Missouri, 63628, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Capital Region Southwest Campus
Jefferson City, Missouri, 65109, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, 65401, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, 65401, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
CoxHealth South Hospital
Springfield, Missouri, 65807, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, 63109, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Missouri Baptist Sullivan Hospital
Sullivan, Missouri, 63080, United States
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills, Missouri, 63127, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Nebraska Hematology and Oncology
Lincoln, Nebraska, 68506, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, 68510, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Faith Regional Health Services Carson Cancer Center
Norfolk, Nebraska, 68701, United States
Great Plains Health Callahan Cancer Center
North Platte, Nebraska, 69101, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Nebraska Cancer Specialists - Omaha
Omaha, Nebraska, 68124, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130, United States
Oncology Hematology West PC
Omaha, Nebraska, 68130, United States
Urology Cancer Center PC
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Regional West Medical Center Cancer Center
Scottsbluff, Nebraska, 69361, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Norris Cotton Cancer Center-Manchester
Manchester, New Hampshire, 03102, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
The Cancer Institute of New Jersey Hamilton
Hamilton, New Jersey, 08690, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, 10461, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467, United States
Dickstein Cancer Treatment Center
White Plains, New York, 10601, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, 28328, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, 28791, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, 28546, United States
Kinston Medical Specialists PA
Kinston, North Carolina, 28501, United States
Cone Heath Cancer Center at Mebane
Mebane, North Carolina, 27302, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, 27893, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Roger Maris Cancer Center
Fargo, North Dakota, 58122, United States
Sanford Broadway Medical Center
Fargo, North Dakota, 58122, United States
Sanford Clinic North-Fargo
Fargo, North Dakota, 58122, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron, Ohio, 44304, United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Oncology Hematology Care Inc-Eden Park
Cincinnati, Ohio, 45202, United States
Oncology Hematology Care Inc-Mercy West
Cincinnati, Ohio, 45211, United States
Oncology Hematology Care Inc - Anderson
Cincinnati, Ohio, 45230, United States
Oncology Hematology Care Inc-Kenwood
Cincinnati, Ohio, 45236, United States
Oncology Hematology Care Inc-Blue Ash
Cincinnati, Ohio, 45242, United States
Columbus Oncology and Hematology Associates Inc
Columbus, Ohio, 43214, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Delaware Health Center-Grady Cancer Center
Delaware, Ohio, 43015, United States
Delaware Radiation Oncology
Delaware, Ohio, 43015, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Oncology Hematology Care Inc-Healthplex
Fairfield, Ohio, 45014, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lancaster Radiation Oncology
Lancaster, Ohio, 43130, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Newark Radiation Oncology
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45662, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, 73120, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa, Oklahoma, 74146, United States
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Ephrata Community Hospital
Ephrata, Pennsylvania, 17522, United States
Adams Cancer Center
Gettysburg, Pennsylvania, 17325, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837, United States
Lewistown Hospital
Lewistown, Pennsylvania, 17044, United States
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301, United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, 19141, United States
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, 17901, United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, 19605, United States
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840, United States
Hematology and Oncology Associates of North East Pennsylvania
Scranton, Pennsylvania, 18508, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Reading Hospital
West Reading, Pennsylvania, 19611, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood, Pennsylvania, 19096, United States
WellSpan Health-York Hospital
York, Pennsylvania, 17403, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, 29640, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, 29341, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29601, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, 29605, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, 29615, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, 29650, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, 29651, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, 29672, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, 29307, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, 37620, United States
Wellmont Medical Associates Oncology and Hematology-Johnson City
Johnson City, Tennessee, 37604, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
Wellmont Medical Associates Oncology and Hematology-Kingsport
Kingsport, Tennessee, 37660, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont College of Medicine
Burlington, Vermont, 05405, United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22908, United States
Sovah Health Martinsville
Martinsville, Virginia, 24115, United States
Southwest VA Regional Cancer Center
Norton, Virginia, 24273, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Marshfield Medical Center
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic-Minocqua Center
Minocqua, Wisconsin, 54548, United States
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017, United States
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Ascension Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Saint Mary's Hospital
Rhinelander, Wisconsin, 54501, United States
Lakeview Medical Center-Marshfield Clinic
Rice Lake, Wisconsin, 54868, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, 54868, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Ascension Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic-Wausau Center
Wausau, Wisconsin, 54401, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Weston Center
Weston, Wisconsin, 54476, United States
Saint Clare's Hospital
Weston, Wisconsin, 54476, United States
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, 54494, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Cheyenne Regional Medical Center-West
Cheyenne, Wyoming, 82001, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (2)
Owonikoko TK, Dahlberg SE, Sica GL, Wagner LI, Wade JL 3rd, Srkalovic G, Lash BW, Leach JW, Leal TB, Aggarwal C, Ramalingam SS. Randomized Phase II Trial of Cisplatin and Etoposide in Combination With Veliparib or Placebo for Extensive-Stage Small-Cell Lung Cancer: ECOG-ACRIN 2511 Study. J Clin Oncol. 2019 Jan 20;37(3):222-229. doi: 10.1200/JCO.18.00264. Epub 2018 Dec 5.
PMID: 30523756RESULTSteffen McLouth LE, Zhao F, Owonikoko TK, Feliciano JL, Mohindra NA, Dahlberg SE, Wade JL 3rd, Srkalovic G, Lash BW, Leach JW, Leal TA, Aggarwal C, Cella D, Ramalingam SS, Wagner LI. Patient-reported tolerability of veliparib combined with cisplatin and etoposide for treatment of extensive stage small cell lung cancer: Neurotoxicity and adherence data from the ECOG ACRIN cancer research group E2511 phase II randomized trial. Cancer Med. 2020 Oct;9(20):7511-7523. doi: 10.1002/cam4.3416. Epub 2020 Aug 28.
PMID: 32860331DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Cancer Research Group
Study Officials
- PRINCIPAL INVESTIGATOR
Taofeek Owonikoko
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2012
First Posted
July 17, 2012
Study Start
September 28, 2012
Primary Completion
December 8, 2016
Study Completion
July 2, 2018
Last Updated
May 6, 2023
Results First Posted
February 5, 2019
Record last verified: 2023-05