Topotecan and Vinorelbine in Treating Patients With 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.
Drug: topotecan hydrochloride
Drug: vinorelbine tartrate
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer|
- Maximum tolerated dose
- Response rate, stable disease rate, and time to progression by RECIST criteria on day 1 of each course
|Study Start Date:||February 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- 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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287963
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Andrew S. Kraft, MD||Medical University of South Carolina|