Carcinoma, Non-Small-Cell Lung
Conditions
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).
Interventions
DRUGgemcitabine/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 \[3-week cycle\]
DRUGcarboplatin/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 \[3-week cycle\]
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed