S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
4 other identifiers
interventional
189
1 country
257
Brief Summary
This randomized phase II trial is studying topotecan to see how well it works when given with or without aflibercept in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combinations of biological substances in aflibercept may be able to carry tumor-killing substances directly to small cell lung cancer cells. Aflibercept may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. It is not yet known whether topotecan is more effective with or without aflibercept in treating patients with 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_2
Started May 2009
Typical duration for phase_2
257 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
January 22, 2009
CompletedFirst Posted
Study publicly available on registry
January 23, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
April 4, 2016
CompletedAugust 21, 2017
July 1, 2017
3.3 years
January 22, 2009
November 5, 2015
July 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Disease assessments were performed every 6 weeks, up to 2 years.
Secondary Outcomes (3)
Overall Survival
Weekly, up to 2 years.
Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)
Disease assessment for response were performed every 6 weeks, up to 2 years.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.
Study Arms (2)
Arm I (ziv-aflibercept, topotecan hydrochloride)
EXPERIMENTALPatients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (topotecan hydrochloride)
ACTIVE COMPARATORPatients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed extensive stage small cell lung cancer
- Progressive or recurrent disease following one (and only one) standard first-line platinum-containing regimen (cisplatin or carboplatin)
- Measurable or non-measurable disease per RECIST criteria
- Disease must be outside a previously irradiated field OR a new lesion must be inside the irradiated field
- Disease must be outside a previously resected area OR a new lesion must be present
- No known brain metastasis unless the metastasis has been treated and is stable for ≥ 3 months prior to study entry
- No leptomeningeal involvement or brain stem metastasis
- Zubrod performance status 0-1
- ANC ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 10 g/dL
- Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 60 mL/min
- Urine protein: creatinine ratio \< 1 OR urine protein \< 500 mg by 24-hour urine collection
- Not pregnant or nursing
- Fertile patients must use effective contraception
- +29 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (257)
Northeast Alabama Regional Medical Center
Anniston, Alabama, 36202, United States
Providence Hospital
Mobile, Alabama, 36608, United States
Arizona Cancer Center at UMC Orange Grove
Tucson, Arizona, 85704, United States
Arizona Cancer Center at University Medical Center North
Tucson, Arizona, 85719, United States
University of Arizona Health Sciences Center
Tucson, Arizona, 85724, United States
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Highlands Oncology Group-Rogers
Rogers, Arkansas, 72758, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
City of Hope Medical Center
Duarte, California, 91010, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
El Camino Hospital
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Breast Surgeons Inc
Oakland, California, 94609, United States
Bay Area Tumor Institute CCOP
Oakland, California, 94609, United States
Larry G Strieff MD Medical Corporation
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
University of California at Davis Cancer Center
Sacramento, California, 95817, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
San Luis Valley Regional Medical Center
Alamosa, Colorado, 81101, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
The Shaw Regional Cancer Center
Edwards, Colorado, 81632, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, 81601, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
Montrose Memorial Hospital
Montrose, Colorado, 81401, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105, United States
Piedmont Hospital
Atlanta, Georgia, 30309, United States
Atlanta Regional CCOP
Atlanta, Georgia, 30342, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, 30342, United States
Well Star Cobb Hospital
Austell, Georgia, 30106, United States
John B Amos Cancer Center
Columbus, Georgia, 31904, United States
Dekalb Medical Center
Decatur, Georgia, 30033, United States
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214, United States
Gwinnett Medical Center
Lawrenceville, Georgia, 30045, United States
Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
Southern Regional Medical Center
Riverdale, Georgia, 30274, United States
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, 30165, United States
Memorial Health University Medical Center
Savannah, Georgia, 31403, United States
South Georgia Medical Center
Valdosta, Georgia, 31603, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Cancer Care Center of Decatur
Decatur, Illinois, 62526, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Memorial Medical Center
Springfield, Illinois, 62781-0001, United States
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, 46107, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
Genesis Medical Center - East Campus
Davenport, Iowa, 52803, United States
Genesis Medical Center - West Campus
Davenport, Iowa, 52804, United States
Hospital District Sixth of Harper County
Anthony, Kansas, 67003, 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
Hays Medical Center
Hays, Kansas, 67601, United States
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, 65702, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Kansas City Cancer Center-West
Kansas City, Kansas, 66112, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, 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, 67901, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Olathe Cancer Center
Olathe, Kansas, 66061, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, 66762, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Salina Regional Health Center
Salina, Kansas, 67401, United States
Stormont-Vail Regional Health Center
Topeka, Kansas, 66604, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, 66606, 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 - Main Office
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wichita CCOP
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Interim LSU Public Hospital
New Orleans, Louisiana, 70112, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Holy Family Hospital
Methuen, Massachusetts, 01844, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, 48106, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Oakwood Hospital
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341-2985, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Gulfport Memorial Hospital
Gulfport, Mississippi, 39502, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Singing River Hospital
Pascagoula, Mississippi, 39581, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Kansas City Veterans Affairs Medical Center
Kansas City, Missouri, 64128, United States
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, 65802, 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
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Saint John's Mercy Medical Center
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Montana Cancer Consortium CCOP
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, 59102, United States
Billings Clinic
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, 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
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Big Sky Oncology
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59801, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, 89106, United States
Arnot Ogden Medical Center
Elmira, New York, 14905, United States
Adirondack Cancer Center
Glens Falls, New York, 12801, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Columbia University Medical Center
New York, New York, 10032, United States
Highland Hospital
Rochester, New York, 14620, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623, United States
University of Rochester
Rochester, New York, 14642, United States
Randolph Hospital
Asheboro, North Carolina, 27203, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, 28204, United States
Carolinas Medical Center - Northeast
Concord, North Carolina, 28025, United States
Gaston Memorial Hospital
Gastonia, North Carolina, 28054, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Cone Health Cancer Center
Greensboro, North Carolina, 27403, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
High Point Regional Hospital
High Point, North Carolina, 27261, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, 27320, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Iredell Memorial Hospital
Statesville, North Carolina, 28677, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus CCOP
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, 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
Dayton CCOP
Dayton, Ohio, 45420, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, 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
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
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
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis HealthCare System
Zanesville, Ohio, 43701, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, 97015, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Newberg Medical Center
Newberg, Oregon, 97132, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 97045, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Western Oncology Research Consortium
Portland, Oregon, 97213, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Salem Hospital
Salem, Oregon, 97301, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
McLeod Regional Medical Center
Florence, South Carolina, 29506, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303, United States
Upstate Carolina CCOP
Spartanburg, South Carolina, 29303, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104, United States
University of Tennessee - Memphis
Memphis, Tennessee, 38163, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555-0565, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Ben Taub General Hospital
Houston, Texas, 77030, United States
Methodist Hospital
Houston, Texas, 77030, United States
Saint Luke's Episcopal Hospital
Houston, Texas, 77030, United States
Veterans Administration Medical Center
Houston, Texas, 77030, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, 79430, United States
Southwest Oncology Group
San Antonio, Texas, 78245, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, 24115, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Highline Medical Center-Main Campus
Burien, Washington, 98166, United States
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
Group Health Cooperative-Seattle
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
United General Hospital
Sedro-Woolley, Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
Rockwood Clinic
Spokane, Washington, 99220, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
Compass Oncology Vancouver
Vancouver, Washington, 98684, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (2)
Lara PN Jr, Moon J, Redman MW, Semrad TJ, Kelly K, Allen JW, Gitlitz BJ, Mack PC, Gandara DR. Relevance of platinum-sensitivity status in relapsed/refractory extensive-stage small-cell lung cancer in the modern era: a patient-level analysis of southwest oncology group trials. J Thorac Oncol. 2015 Jan;10(1):110-5. doi: 10.1097/JTO.0000000000000385.
PMID: 25490004DERIVEDAllen JW, Moon J, Redman M, Gadgeel SM, Kelly K, Mack PC, Saba HM, Mohamed MK, Jahanzeb M, Gandara DR. Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer. J Clin Oncol. 2014 Aug 10;32(23):2463-70. doi: 10.1200/JCO.2013.51.4109. Epub 2014 Jul 7.
PMID: 25002722DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Lung Committee Statistician
- Organization
- SWOG Statistical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Allen
SWOG Cancer Research Network
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2009
First Posted
January 23, 2009
Study Start
May 1, 2009
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
August 21, 2017
Results First Posted
April 4, 2016
Record last verified: 2017-07