Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)

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).

• Drug: 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]
• Drug: 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]

• Active Comparator: 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
  Intervention: Drug: gemcitabine/Eloxatin (GEMOX)
• Active Comparator: 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).
  Intervention: Drug: carboplatin/paclitaxel (CP)

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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