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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Maximum tolerated dose
Time frame: Cycle 1 (up to day 21)
Response rate
Time frame: while on study, at the end of each 3 week cycle
stable disease rate
Time frame: while on study, at the end of each 3 week cycle
time to progression
Time frame: from start of treatment to day of documented progression or death, whichever comes first, up to 36 months
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