Spots Global Cancer Trial Database for Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

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Trial Identification

Brief Title: Epothilone D in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer That Has Not Responded to Platinum-Based Chemotherapy

Official Title: A Phase II Study of KOS-862, Administered Intravenously Weekly for 3 Weeks Every 4 Weeks, in Patients With Non-Small Cell Lung Cancer Who Have Progressed Following Initial Therapy for Advanced or Metastatic Disease

Study ID: NCT00081107

Conditions

Lung Cancer

Interventions

epothilone D

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as epothilone D, work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well epothilone D works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to platinum-based chemotherapy.

Detailed Description: OBJECTIVES: Primary * Determine the antitumor activity of epothilone D, in terms of confirmed objective response rate, in patients with stage IIIB or IV non-small cell lung cancer who failed prior initial platinum-containing chemotherapy. Secondary * Determine the safety of this drug in these patients. * Determine the response duration in patients who achieve complete response or partial response, time to tumor progression, and survival in patients treated with this drug. * Compare the power associated with the estimated treatment effect of this drug in these patients vs standard treatment. * Correlate efficacy and safety with plasma concentrations of this drug and its major metabolites in these patients. OUTLINE: This is a multicenter, open-label study. Patients receive epothilone D IV over 90 minutes on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 33-85 patients will be accrued for this study.