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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
383
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 \[3-week cycle\]
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
Time frame: 22 months
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