Spots Global Cancer Trial Database for Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

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Trial Identification

Brief Title: Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

Official Title: The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer

Study ID: NCT00087048

Conditions

Lung Cancer

Interventions

topotecan hydrochloride

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as topotecan, 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 high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.

Detailed Description: OBJECTIVES: Primary * Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride. Secondary * Determine the safety and toxic effects of this drug in these patients. * Determine the recurrence-free survival of patients treated with this drug. * Determine time to response and tumor response in patients treated with this drug. * Determine the quality of life of patients treated with this drug. OUTLINE: This is a non-randomized, multicenter study. Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter. Patients are followed at 7-14 days and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.