Spots Global Cancer Trial Database for TLK286 in Treating Patients With Advanced Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: TLK286 in Treating Patients With Advanced Non-Small Cell Lung Cancer

Official Title: Phase II Study Of TLK286 For The Treatment Of Advanced Non-Small Cell Lung Cancer

Study ID: NCT00036920

Conditions

Lung Cancer

Interventions

canfosfamide hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of TLK286 in treating patients who have advanced non-small cell lung cancer.

Detailed Description: OBJECTIVES: I. Determine the 12-month survival of patients with advanced non-small cell lung cancer treated with TLK286. II. Determine the overall survival of patients treated with this drug. III. Determine the objective response rate, duration of objective response, time to tumor progression, and disease stabilization in patients treated with this drug. IV. Determine the safety of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive TLK286 IV over 30 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks for 1 year and then every 12 weeks thereafter. PROJECTED ACCRUAL: Approximately 55 patients will be accrued for this study within 12 months.