Status:
COMPLETED
Gemcitabine/Oxaliplatin (GEMOX) vs Carboplatin/Paclitaxel (CP) in Non-Small Cell Lung Cancer (NSCLC)
Lead Sponsor:
Sanofi
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 betwe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT00087802
Start Date
March 1 2004
Last Update
April 16 2009
Active Locations (70)
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1
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, United States, 35235
2
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States, 35235
3
Hematology Oncology Associates
Phoenix, Arizona, United States, 85012
4
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336