Study Stopped
Slow accrual
Pemetrexed Disodium or Erlotinib Hydrochloride as Second-Line Therapy in Treating Patients With Advanced Non-small Cell Lung Cancer
MARVEL
MARVEL: Marker Validation of Erlotinib in Lung Cancer- A Phase III Biomarker Validation Study of Second-Line Therapy in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Randomized to Pemetrexed Versus Erlotinib
8 other identifiers
interventional
23
2 countries
269
Brief Summary
This randomized phase III trial studies pemetrexed disodium to see how well it works compared with erlotinib hydrochloride as second-line therapy in treating patients with non-small cell lung cancer that has spread to other places in the body. Pemetrexed disodium and erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pemetrexed disodium is more effective than erlotinib hydrochloride in treating advanced non-small cell lung cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2008
Longer than P75 for phase_3
269 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
August 20, 2008
CompletedFirst Posted
Study publicly available on registry
August 21, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedResults Posted
Study results publicly available
October 2, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 29, 2015
December 1, 2014
3.2 years
August 20, 2008
November 27, 2013
October 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
Estimated using the method of Kaplan-Meier survival curves to compare PFS between the erlotinib and pemetrexed arms using an intent-to-treat (ITT) analysis. Due to the small sample size (21 of the required 954 patients \~2%), analyses within the FISH(+) and FISH(-) groups were not performed, and no formal analyses for the primary or the secondary efficacy outcomes were performed.
Time from randomization to the first date of documented disease progression or death, assessed up to 5 years
Secondary Outcomes (3)
Time to Treatment Failure
The time from date of randomization to the date at which the patient is removed from the treatment, assessed up to 5 years
Overall Survival
Time from randomization to time of death from any cause, assessed up to 5 years
Confirmed Response Rate Defined as Complete Response (CR) or a Partial Response (PR) Per Response Evaluation Criteria In Solid Tumors (RECIST)
Up to 5 years
Study Arms (2)
Arm I (erlotinib hydrochloride)
EXPERIMENTALPatients receive erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm II (pemetrexed disodium)
EXPERIMENTALPatients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given PO
Given IV
Eligibility Criteria
You may qualify if:
- Documented recurrence or disease progression of NSCLC
- NSCLC must be confirmed by pathologic examination, either on initial diagnosis or disease recurrence/progression; mixed histology allowed if all components consistent with NSCLC
- Measurable disease, defined as at least one lesion whose longest diameter can be accurately measured as \>= 2.0 cm by conventional techniques or as \>= 1.0 cm by spiral computed tomography (CT); if spiral CT is used, it must be used for both pre- and post- treatment tumor assessments
- Prior radiation therapy is permitted as long as:
- Recovered from the toxic effects of radiation treatment before study entry, except for alopecia
- =\< 25% of bone marrow radiated
- Presence of measurable disease whether in-field disease progression/recurrence or disease outside the treatment fields of radiation port
- Absolute neutrophil count (ANC) \>= 1,500 uL
- Platelet (PLT) \>= 100,000 uL
- Hemoglobin (Hgb) \>= 10 g/dL
- Total bilirubin: within normal institutional limits (WNL) OR direct bilirubin =\< upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x ULN
- International normalized ratio (INR) =\< 1.5
- Calculated creatinine clearance \>= 45 mL/min using the Cockcroft-Gault formula
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2
- +11 more criteria
You may not qualify if:
- Any of the following:
- Pregnant women
- Nursing women
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Any clinically significant infection, at the treating physician's discretion
- Known human immunodeficiency virus (HIV) positive patients
- Impairment of gastrointestinal (GI) function, inability to swallow pills in the absence of a feeding tube, or GI disease that may significantly alter absorption of oral medications (e.g. ulcerative disease, uncontrolled nausea and vomiting, malabsorption syndromes, bowel obstruction, etc)
- Serious condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study or increase the risk for serious adverse events
- Any of the following prior therapies:
- Prior radiation to \> 25% of bone marrow
- EGFR tyrosine kinase inhibitors
- Pemetrexed
- Chemotherapy =\< 3 weeks prior to pre-registration
- Mitomycin C/nitrosoureas =\< 6 weeks prior to pre-registration
- Immunotherapy =\< 2 weeks prior to pre-registration
- +28 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Cancer and Leukemia Group Bcollaborator
- Eastern Cooperative Oncology Groupcollaborator
- NCIC Clinical Trials Groupcollaborator
- SWOG Cancer Research Networkcollaborator
Study Sites (269)
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901, United States
Kaiser Permanente-Deer Valley Medical Center
Antioch, California, 94531, United States
Kaiser Permanente-Fremont
Fremont, California, 94538, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Kaiser Permanente-Oakland
Oakland, California, 94611, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Kaiser Permanente-Redwood City
Redwood City, California, 94063, United States
Kaiser Permanente-Richmond
Richmond, California, 94801, United States
Kaiser Permanente-Roseville
Roseville, California, 95661, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Kaiser Permanente-South Sacramento
Sacramento, California, 95823, United States
Kaiser Permanente - Sacramento
Sacramento, California, 95825, United States
Kaiser Permanente-San Francisco
San Francisco, California, 94115, United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, 95119, United States
Kaiser Permanente San Leandro
San Leandro, California, 94577, United States
Kaiser Permanente-San Rafael
San Rafael, California, 94903, United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California, 95403, United States
Kaiser Permanente-South San Francisco
South San Francisco, California, 94080, United States
Kaiser Permanente-Stockton
Stockton, California, 95210, United States
Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Kaiser Permanente Medical Center-Vacaville
Vacaville, California, 95688, United States
Kaiser Permanente-Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California, 94596, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program CCOP
Denver, Colorado, 80224-2522, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Bristol Hospital
Bristol, Connecticut, 06011, United States
Middlesex Hospital
Middletown, Connecticut, 06457, United States
Lynn Regional Cancer Center - West
Boca Raton, Florida, 33428, United States
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 33486, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
MacNeal Hospital and Cancer Center
Berwyn, Illinois, 60402, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Cottage
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Midwest Center for Hematology Oncology
Joliet, Illinois, 60432, 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
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
DuPage Medical Group-Ogden
Naperville, Illinois, 60563, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
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
Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC
Peoria, Illinois, 61615-7827, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Illinois Oncology Research Association CCOP
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Franciscan St. Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010, United States
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, 52722, United States
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, 52403, 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
Genesis Medical Center - West Campus
Davenport, Iowa, 52804, United States
Mercy Capitol
Des Moines, Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa Oncology Research Association CCOP
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
Mercy Medical Center - Des Moines
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
Covenant Medical Center
Waterloo, Iowa, 50702, United States
Hospital District Sixth of Harper County
Anthony, Kansas, 67003, United States
Menorah Medical Center
Overland Park, Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park, Kansas, 66213, United States
Shawnee Mission Medical Center-KCCC
Shawnee Mission, Kansas, 66204, United States
Stormont-Vail Regional Health Center
Topeka, Kansas, 66604, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
The Memorial Hospital at Easton
Easton, Maryland, 21601, United States
Cancer Trials Support Unit
Rockville, Maryland, 20850-2062, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Steward Saint Elizabeth's Medical Center
Brighton, Massachusetts, 02135-2997, United States
Cape Cod Hospital
Hyannis, Massachusetts, 02601, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, 48106, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, 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 Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, 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
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
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Minnesota Cooperative Group Outreach Program
Minneapolis, Minnesota, 55407, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Truman Medical Center
Kansas City, Missouri, 64108, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Joseph Health Center
Kansas City, Missouri, 64114, United States
North Kansas City Hospital
Kansas City, Missouri, 64116, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, 64086, United States
Liberty Hospital
Liberty, Missouri, 64068, United States
Liberty Radiation Oncology Center
Liberty, Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, 64506, United States
Saint Louis University Hospital
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, 59102, United States
Billings Clinic Cancer Center
Billings, Montana, 59107, 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
Berdeaux, Donald MD (UIA Investigator)
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
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Veterans Adminstration New Jersey Health Care System
East Orange, New Jersey, 07018-1095, United States
Hunterdon Medical Center
Flemington, New Jersey, 08822, United States
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, 08060, United States
Riverview Medical Center/Booker Cancer Center
Red Bank, New Jersey, 07701, United States
Virtua West Jersey Hospital Voorhees
Voorhees Township, New Jersey, 08043, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Syracuse Veterans Administration Medical Center
Syracuse, New York, 13210, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Southeast Cancer Consortium-Upstate NCORP
Winston-Salem, North Carolina, 27104, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Saint Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, 43410, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, 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
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, 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
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Saint Luke's Hospital
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Mercy Hospital
Scranton, Pennsylvania, 18501, United States
Scranton Hematology Oncology
Scranton, Pennsylvania, 18510, United States
Geisinger Medical Group
State College, Pennsylvania, 16801, United States
Mount Nittany Medical Center
State College, Pennsylvania, 16803, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
Memorial Hospital Of Martinsville
Martinsville, Virginia, 24115, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alex A. Adjei, M.D., Ph.D
- Organization
- Roswell Park Cancer Institute
Study Officials
- PRINCIPAL INVESTIGATOR
Alex Adjei
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2008
First Posted
August 21, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2014
Last Updated
October 29, 2015
Results First Posted
October 2, 2014
Record last verified: 2014-12