Spots Global Cancer Trial Database for Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

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Trial Identification

Brief Title: Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Official Title: A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer

Study ID: NCT00287963

Conditions

Lung Cancer

Interventions

topotecan hydrochloride

vinorelbine tartrate

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.

Detailed Description: OBJECTIVES: Primary * Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer. Secondary * Assess the response and stable disease rates and the time to disease progression among treated patients. OUTLINE: This is a dose-escalation study of topotecan. Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.