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).

Official Title

A Phase III Randomized Trial of Gemcitabine/Oxaliplatin (GEMOX) versus Carboplatin/Paclitaxel (CP) as First-line Therapy in Patients with Advanced Non-small Cell Lung Cancer (NSCLC)

Conditions

– Carcinoma, Non-Small-Cell Lung

Study Type

– Interventional

Study Design

– Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

March 2004

Eligibility & Criteria

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

Total Enrolment

480

Contact Details

– Stephanie Mull 832-601-6475 stephanie.mull@usoncology.com- Sharon Pritchard 214-584-3217 sharon.pritchard@usoncology.com