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.
๐บ๐ธKettering, Ohio, United States
Interlakes Oncology & Hematology, P.C.
๐บ๐ธRochester, New York, United States
Florida Cancer Institute
๐บ๐ธNew Port Richey, Florida, United States
Berkshire Hematology Oncology, PC
๐บ๐ธPittsfield, Massachusetts, United States
Maryland Oncology Hematology, P.A.
๐บ๐ธColumbia, Maryland, United States
New York Oncology Hematology, P.C.
๐บ๐ธRexford, New York, United States
New York Oncology Hematology
๐บ๐ธLatham, New York, United States
Raleigh Hematology Oncology Clinic
๐บ๐ธCary, North Carolina, United States
Cancer Centers of the Carolinas
๐บ๐ธSeneca, South Carolina, United States
Texas Cancer Center - Sherman
๐บ๐ธSherman, Texas, United States
Tyler Cancer Center
๐บ๐ธTyler, Texas, United States
Waco Cancer Care and Research Center
๐บ๐ธWaco, Texas, United States
Northwest Cancer Specialists, P.C.
๐บ๐ธVancouver, Washington, United States
Cancer Care Northwest
๐บ๐ธSpokane, Washington, United States
Northern Arizona Hematology & Oncology Associates
๐บ๐ธSedona, Arizona, United States
Arizona Oncology Associates - Hematology Oncology Physicians
๐บ๐ธTucson, Arizona, United States
South Florida Oncology & Hematology Consultants
๐บ๐ธPlantation, Florida, United States
Ocala Oncology Center
๐บ๐ธOcala, Florida, United States
Arch Medical Services, Inc.
๐บ๐ธSt. Louis, Missouri, United States
Fairfax Northern Virginia Hematology Oncology, PC
๐บ๐ธFairfax, Virginia, United States
Cancer Centers of Florida, P.A.
๐บ๐ธOcoee, Florida, United States
New Mexico Cancer Care Associates
๐บ๐ธSanta Fe, New Mexico, United States
Missouri Cancer Associates
๐บ๐ธColumbia, Missouri, United States
Cancer Care Associates
๐บ๐ธTulsa, Oklahoma, United States
Mamie McFaddin Ward Cancer Center
๐บ๐ธBeaumont, Texas, United States
Deke Slayton Cancer Center
๐บ๐ธWebster, Texas, United States
Northwest Medical Specialists, PC
๐บ๐ธNiles, Illinois, United States
Oncology Associates of Cedar Rapids
๐บ๐ธCedar Rapids, Iowa, United States
Hematology Oncology Associates of Illinois
๐บ๐ธSkokie, Illinois, United States
Kansas City Oncology and Hematology Group
๐บ๐ธOverland Park, Kansas, United States
Willamette Valley Cancer Center
๐บ๐ธEugene, Oregon, United States
Texas Oncology, P.A.
๐บ๐ธIrving, Texas, United States
Texas Cancer Center - Abilene
๐บ๐ธAbilene, Texas, United States
The Texas Cancer Center
๐บ๐ธDallas, Texas, United States
Texas Cancer Center at Medical City
๐บ๐ธDallas, Texas, United States
El Paso Cancer Treatment Ctr-East
๐บ๐ธEl Paso, Texas, United States
San Antonio Tumor and Blood Clinic
๐บ๐ธFredericksburg, Texas, United States
Texas Cancer Center - Denton
๐บ๐ธDenton, Texas, United States
Texas Oncology Cancer Center
๐บ๐ธAustin, Texas, United States
Longview Cancer Center
๐บ๐ธLongview, Texas, United States
South Texas Cancer Center - McAllen
๐บ๐ธMcAllen, Texas, United States
Lake Vista Cancer Center
๐บ๐ธLewisville, Texas, United States
Allison Cancer Center
๐บ๐ธMidland, Texas, United States
West Texas Cancer Center
๐บ๐ธOdessa, Texas, United States
Texas Cancer Center of Mesquite
๐บ๐ธMesquite, Texas, United States
Paris Regional Cancer Center
๐บ๐ธParis, Texas, United States
Virginia Oncology Associates
๐บ๐ธNorfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
๐บ๐ธSalem, Virginia, United States
Birmingham Hematology and Oncology Associates, LLC
๐บ๐ธBirmingham, Alabama, United States
Birmingham Hematology and Oncology Associates
๐บ๐ธBirmingham, Alabama, United States
Hematology Oncology Associates
๐บ๐ธPhoenix, Arizona, United States
Rocky Mountain Cancer Centers
๐บ๐ธDenver, Colorado, United States
Central Indiana Cancer Centers
๐บ๐ธIndianapolis, Indiana, United States
Minnesota Oncology Hematology, P.A.
๐บ๐ธMinneapolis, Minnesota, United States
Minnesota Oncology Hematology
๐บ๐ธMinneapolis, Minnesota, United States
Comprehensive Cancer Centers of Nevada
๐บ๐ธLas Vegas, Nevada, United States
Piedmont Hematology Oncology Associates, PLLC.
๐บ๐ธWinston-Salem, North Carolina, United States
Puget Sound Cancer Centers
๐บ๐ธSeattle, Washington, United States
Hematology Oncology Associates of South Texas
๐บ๐ธSan Antonio, Texas, United States