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

Completed · Phase 3

Conditions studied: Carcinoma, Non-Small-Cell Lung

In brief

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).

Key facts

Study ID

NCT00087802

Run by

Sanofi

People needed

383

Starts

2004-03-01

Last updated by the study team

2009-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Birmingham Hematology and Oncology Associates, LLC — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.