Lung Cancer Clinical Trial
Official title:
A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
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.
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.
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