Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)
A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) Versus Carboplatin/Paclitaxel (CP) as First-Line Therapy in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)
2 other identifiers
interventional
383
1 country
70
Brief Summary
The purpose of this study is to compare combination treatment of gemcitabine + oxaliplatin (GEMOX) with carboplatin + paclitaxel (CP) to determine if there is a difference in response and safety between the two drug combinations for the treatment of advanced non-small cell lung cancer (NSCLC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
70 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
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 13, 2004
CompletedFirst Posted
Study publicly available on registry
July 16, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2007
CompletedApril 16, 2009
April 1, 2009
3.2 years
July 13, 2004
April 15, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the relative efficacy, safety and clinical benefit of the GEMOX regimen compared to the standard combination regimen of CP as first-line treatment of Stage IIIB and IV NSCLC
22 months
Study Arms (2)
Stratum 1
ACTIVE COMPARATORSubjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally
Stratum 2
ACTIVE COMPARATORSubjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease).
Interventions
GEMOX \[gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle\] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days \[3-week cycle\]
CP \[carboplatin/paclitaxel - 21 day cycle\] o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days \[3-week cycle\]
Eligibility Criteria
You may qualify if:
- Newly diagnosed, Stage IIIb or IV NSCLC, chemo or other systemic therapy naive
- One (1) unidimensionally measurable lesion
- ECOG Performance Status of 0 or 1, no peripheral neuropathy \>Grade 1
- Patients with clinically stable brain metastases on a stable dose of (or no longer requiring) dexamethasone at registration will be eligible. Patients who have received cranial radiation for brain metastases must be at least 4 weeks from last radiation treatment.
- Recovery in full from any previous surgical procedure
- No history of an acute cardiac or CNS event within 6 months of entry or current clinical evidence of congestive heart failure or non-stable coronary artery disease
You may not qualify if:
- Hypersensitivity to any of the 4 study drugs
- Concurrent immunotherapy or participation in any investigational drug study within 4 weeks
- Serious uncontrolled intercurrent medical or psychiatric illness and organ allograft
- History of other malignancy within the last 5 years (except for squamous or basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial transitional cell carcinoma of the bladder)
- Patient is a pregnant or lactating female
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (70)
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35235, United States
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, 35235, United States
Hematology Oncology Associates
Phoenix, Arizona, 85012, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336, United States
Arizona Oncology Associates - Hematology Oncology Physicians
Tucson, Arizona, 85704, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Florida Cancer Institute
New Port Richey, Florida, 34652, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, 34761, United States
South Florida Oncology & Hematology Consultants
Plantation, Florida, 33324, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, 60611, United States
Northwest Medical Specialists, PC
Niles, Illinois, 60714, United States
Hematology Oncology Associates of Illinois
Skokie, Illinois, 60077, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Oncology Associates of Cedar Rapids
Cedar Rapids, Iowa, 52403, United States
Kansas City Oncology and Hematology Group
Overland Park, Kansas, 66210, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, 01201, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, 55404, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Arch Medical Services, Inc.
St Louis, Missouri, 63141, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
New York Oncology Hematology
Latham, New York, 12110, United States
New York Oncology Hematology, P.C.
Rexford, New York, 12148, United States
Interlakes Oncology & Hematology, P.C.
Rochester, New York, 14623, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, 27511, United States
Piedmont Hematology Oncology Associates, PLLC.
Winston-Salem, North Carolina, 27103, United States
Dayton Oncology & Hematology, P.A.
Kettering, Ohio, 45409, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73120, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136-1902, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, 29672, United States
Texas Cancer Center - Abilene
Abilene, Texas, 79606, United States
Texas Oncology, P.A.
Arlington, Texas, 76012, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, 77702-1449, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Texas Cancer Center at Medical City
Dallas, Texas, 75230-2510, United States
Texas Oncology, P.A.
Dallas, Texas, 75231, United States
The Texas Cancer Center
Dallas, Texas, 75237, United States
Texas Oncology, P.A.
Dallas, Texas, 75246, United States
Texas Cancer Center - Denton
Denton, Texas, 76210, United States
El Paso Cancer Treatment Ctr-East
El Paso, Texas, 79915, United States
Texas Oncology, P.A.
Fort Worth, Texas, 76104, United States
San Antonio Tumor and Blood Clinic
Fredericksburg, Texas, 78624, United States
Texas Oncology, P.A.
Garland, Texas, 75042-5788, United States
Texas Oncology, P.A.
Houston, Texas, 77024, United States
Texas Oncology, P.A.
Irving, Texas, 75061-2244, United States
Lake Vista Cancer Center
Lewisville, Texas, 75067, United States
Longview Cancer Center
Longview, Texas, 75601, United States
South Texas Cancer Center - McAllen
McAllen, Texas, 78503-1298, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Allison Cancer Center
Midland, Texas, 79701-5946, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
Paris Regional Cancer Center
Paris, Texas, 75460, United States
Hematology Oncology Associates of South Texas
San Antonio, Texas, 78229, United States
Texas Cancer Center - Sherman
Sherman, Texas, 75090-0504, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Waco Cancer Care and Research Center
Waco, Texas, 76712, United States
Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, 24153, United States
Puget Sound Cancer Centers
Edmonds, Washington, 98026, United States
Puget Sound Cancer Centers
Seattle, Washington, 98133, United States
Cancer Care Northwest
Spokane, Washington, 99218, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98684, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yasir Nagarwala, MD
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 13, 2004
First Posted
July 16, 2004
Study Start
March 1, 2004
Primary Completion
May 1, 2007
Last Updated
April 16, 2009
Record last verified: 2009-04