Spots Global Cancer Trial Database for Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer

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Trial Identification

Brief Title: Temozolomide in Treating Patients With Relapsed or Progressive Small Cell Lung Cancer

Official Title: A Phase II Study of Temozolomide (SCH 52365) in the Treatment of Patients With Relapsed Small Cell Lung Cancer

Study ID: NCT00022711

Conditions

Lung Cancer

Interventions

temozolomide

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 temozolomide in treating patients who have relapsed or progressive small cell lung cancer.

Detailed Description: OBJECTIVES: * Determine the efficacy of temozolomide, in terms of response rate and safety, in patients with relapsed or progressive small cell lung cancer. * Determine the time to progression and overall survival in patients treated with this drug. * Assess quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior chemotherapy (chemosensitive at least 60 days after prior therapy vs chemoresistant less than 60 days after or progression during prior therapy). Patients receive oral temozolomide once daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to each course of chemotherapy, at 30 days after study completion, and then every 8 weeks thereafter. Patients are followed at 30 days and then every 8 weeks thereafter. PROJECTED ACCRUAL: A total of 37-79 patients (14-33 chemosensitive and 23-46 chemoresistant) will be accrued for this study.