Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- Drug: gemcitabine/Eloxatin (GEMOX)Drug: carboplatin/paclitaxel (CP)
- Registration Number
- NCT00087802
- Lead Sponsor
- Sanofi
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 383
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stratum 1 gemcitabine/Eloxatin (GEMOX) Subjects 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 carboplatin/paclitaxel (CP) Subjects 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).
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (59)
Dayton Oncology & Hematology, P.A.
🇺🇸Kettering, Ohio, United States
Interlakes Oncology & Hematology, P.C.
🇺🇸Rochester, New York, United States
Florida Cancer Institute
🇺🇸New Port Richey, Florida, United States
Berkshire Hematology Oncology, PC
🇺🇸Pittsfield, Massachusetts, United States
Maryland Oncology Hematology, P.A.
🇺🇸Columbia, Maryland, United States
New York Oncology Hematology, P.C.
🇺🇸Rexford, New York, United States
New York Oncology Hematology
🇺🇸Latham, New York, United States
Raleigh Hematology Oncology Clinic
🇺🇸Cary, North Carolina, United States
Cancer Centers of the Carolinas
🇺🇸Seneca, South Carolina, United States
Texas Cancer Center - Sherman
🇺🇸Sherman, Texas, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
Waco Cancer Care and Research Center
🇺🇸Waco, Texas, United States
Northwest Cancer Specialists, P.C.
🇺🇸Vancouver, Washington, United States
Cancer Care Northwest
🇺🇸Spokane, Washington, United States
Northern Arizona Hematology & Oncology Associates
🇺🇸Sedona, Arizona, United States
Arizona Oncology Associates - Hematology Oncology Physicians
🇺🇸Tucson, Arizona, United States
South Florida Oncology & Hematology Consultants
🇺🇸Plantation, Florida, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Arch Medical Services, Inc.
🇺🇸St. Louis, Missouri, United States
Fairfax Northern Virginia Hematology Oncology, PC
🇺🇸Fairfax, Virginia, United States
Cancer Centers of Florida, P.A.
🇺🇸Ocoee, Florida, United States
New Mexico Cancer Care Associates
🇺🇸Santa Fe, New Mexico, United States
Missouri Cancer Associates
🇺🇸Columbia, Missouri, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Mamie McFaddin Ward Cancer Center
🇺🇸Beaumont, Texas, United States
Deke Slayton Cancer Center
🇺🇸Webster, Texas, United States
Northwest Medical Specialists, PC
🇺🇸Niles, Illinois, United States
Oncology Associates of Cedar Rapids
🇺🇸Cedar Rapids, Iowa, United States
Hematology Oncology Associates of Illinois
🇺🇸Skokie, Illinois, United States
Kansas City Oncology and Hematology Group
🇺🇸Overland Park, Kansas, United States
Willamette Valley Cancer Center
🇺🇸Eugene, Oregon, United States
Texas Oncology, P.A.
🇺🇸Irving, Texas, United States
Texas Cancer Center - Abilene
🇺🇸Abilene, Texas, United States
The Texas Cancer Center
🇺🇸Dallas, Texas, United States
Texas Cancer Center at Medical City
🇺🇸Dallas, Texas, United States
El Paso Cancer Treatment Ctr-East
🇺🇸El Paso, Texas, United States
San Antonio Tumor and Blood Clinic
🇺🇸Fredericksburg, Texas, United States
Texas Cancer Center - Denton
🇺🇸Denton, Texas, United States
Texas Oncology Cancer Center
🇺🇸Austin, Texas, United States
Longview Cancer Center
🇺🇸Longview, Texas, United States
South Texas Cancer Center - McAllen
🇺🇸McAllen, Texas, United States
Lake Vista Cancer Center
🇺🇸Lewisville, Texas, United States
Allison Cancer Center
🇺🇸Midland, Texas, United States
West Texas Cancer Center
🇺🇸Odessa, Texas, United States
Texas Cancer Center of Mesquite
🇺🇸Mesquite, Texas, United States
Paris Regional Cancer Center
🇺🇸Paris, Texas, United States
Virginia Oncology Associates
🇺🇸Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
🇺🇸Salem, Virginia, United States
Birmingham Hematology and Oncology Associates, LLC
🇺🇸Birmingham, Alabama, United States
Birmingham Hematology and Oncology Associates
🇺🇸Birmingham, Alabama, United States
Hematology Oncology Associates
🇺🇸Phoenix, Arizona, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Central Indiana Cancer Centers
🇺🇸Indianapolis, Indiana, United States
Minnesota Oncology Hematology, P.A.
🇺🇸Minneapolis, Minnesota, United States
Minnesota Oncology Hematology
🇺🇸Minneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Las Vegas, Nevada, United States
Piedmont Hematology Oncology Associates, PLLC.
🇺🇸Winston-Salem, North Carolina, United States
Puget Sound Cancer Centers
🇺🇸Seattle, Washington, United States
Hematology Oncology Associates of South Texas
🇺🇸San Antonio, Texas, United States