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

Phase 3

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: gemcitabine/Eloxatin (GEMOX); Drug: carboplatin/paclitaxel (CP)

• Registration Number: NCT00087802
• Lead Sponsor: Sanofi

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-07-13
• Study First Submitted QC: 2004-07-15
• Study First Posted: 2004-07-16
• Primary Completion: 2007-05
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-15
• Last Update Posted: 2009-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 383

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stratum 1	gemcitabine/Eloxatin (GEMOX)	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
Stratum 2	carboplatin/paclitaxel (CP)	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).

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (59)

Birmingham Hematology and Oncology Associates, LLC; 🇺🇸 Birmingham, Alabama, United States

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

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