Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)
NCT ID: NCT00087802
Last Updated: 2009-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
383 participants
INTERVENTIONAL
2004-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stratum 1
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
gemcitabine/Eloxatin (GEMOX)
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 \[3-week cycle\]
Stratum 2
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).
carboplatin/paclitaxel (CP)
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 \[3-week cycle\]
Interventions
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gemcitabine/Eloxatin (GEMOX)
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 \[3-week cycle\]
carboplatin/paclitaxel (CP)
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
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Yasir Nagarwala, MD
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States
Arizona Oncology Associates - Hematology Oncology Physicians
Tucson, Arizona, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States
South Florida Oncology & Hematology Consultants
Plantation, Florida, United States
Hematology Oncology Associates of Illinois
Chicago, Illinois, United States
Northwest Medical Specialists, PC
Niles, Illinois, United States
Hematology Oncology Associates of Illinois
Skokie, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Oncology Associates of Cedar Rapids
Cedar Rapids, Iowa, United States
Kansas City Oncology and Hematology Group
Overland Park, Kansas, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States
Berkshire Hematology Oncology, PC
Pittsfield, Massachusetts, United States
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States
Minnesota Oncology Hematology
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Arch Medical Services, Inc.
St Louis, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
New York Oncology Hematology, P.C.
Albany, New York, United States
New York Oncology Hematology
Latham, New York, United States
New York Oncology Hematology, P.C.
Rexford, New York, United States
Interlakes Oncology & Hematology, P.C.
Rochester, New York, United States
Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States
Piedmont Hematology Oncology Associates, PLLC.
Winston-Salem, North Carolina, United States
Dayton Oncology & Hematology, P.A.
Kettering, Ohio, United States
Cancer Care Associates
Oklahoma City, Oklahoma, United States
Cancer Care Associates
Tulsa, Oklahoma, United States
Willamette Valley Cancer Center
Eugene, Oregon, United States
Cancer Centers of the Carolinas
Seneca, South Carolina, United States
Texas Cancer Center - Abilene
Abilene, Texas, United States
Texas Oncology, P.A.
Arlington, Texas, United States
Texas Oncology Cancer Center
Austin, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology, P.A.
Bedford, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
The Texas Cancer Center
Dallas, Texas, United States
Texas Oncology, P.A.
Dallas, Texas, United States
Texas Cancer Center - Denton
Denton, Texas, United States
El Paso Cancer Treatment Ctr-East
El Paso, Texas, United States
Texas Oncology, P.A.
Fort Worth, Texas, United States
San Antonio Tumor and Blood Clinic
Fredericksburg, Texas, United States
Texas Oncology, P.A.
Garland, Texas, United States
Texas Oncology, P.A.
Houston, Texas, United States
Texas Oncology, P.A.
Irving, Texas, United States
Lake Vista Cancer Center
Lewisville, Texas, United States
Longview Cancer Center
Longview, Texas, United States
South Texas Cancer Center - McAllen
McAllen, Texas, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, United States
Allison Cancer Center
Midland, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
Hematology Oncology Associates of South Texas
San Antonio, Texas, 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
Deke Slayton Cancer Center
Webster, Texas, United States
Fairfax Northern Virginia Hematology Oncology, PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Oncology & Hematology Associates of Southwest Virginia, Inc.
Salem, Virginia, United States
Puget Sound Cancer Centers
Edmonds, Washington, United States
Puget Sound Cancer Centers
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States
Countries
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Other Identifiers
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SR96669
Identifier Type: -
Identifier Source: secondary_id
L_9210
Identifier Type: -
Identifier Source: org_study_id
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