Satraplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer

Phase 2 Trial of First-Line Therapy With Satraplatin and Paclitaxel in Patients With Unresectable Stage III or IV Non-small Cell Lung Cancer (NSCLC)

The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

This trial is designed to study the efficacy and safety of a novel oral platinum analog, satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line of treatment (patients who have not received chemotherapy for disease that has metastasized) of patients with advanced NSCLC. WHAT IS SATRAPLATIN: Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Paclitaxel 200 mg/m2 IV over 3 hours on day 1. Satraplatin 60 mg/m2 administered by mouth once daily for 5 consecutive days (days 1-5). Satraplatin will be administered within 2 hours following paclitaxel infusion on day 1. Subsequent doses on days 2-5 will be taken at approximately 24 hour intervals.

To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel

To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel

Inclusion Criteria: Histologically confirmed advanced NSCLC Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry. Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan. ECOG performance status of ≤ 2.