A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
- Determine the maximum tolerated dose of topotecan when combined with vinorelbine
ditartrate in patients with recurrent lung cancer.
- Assess the response and stable disease rates and the time to disease progression among
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.
Primary Purpose: Treatment
Maximum tolerated dose
Andrew S. Kraft, MD
Medical University of South Carolina
United States: Federal Government
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|