PHASE I EVALUATION OF TOPOTECAN IN COMBINATION WITH PACLITAXEL AND CARBOPLATIN
OBJECTIVES: I. Determine the maximum tolerated doses of combined topotecan, paclitaxel, and
carboplatin (TOPO/TAX/CBDCA) with or without filgrastim (G-CSF) in patients with advanced
solid tumors or lymphomas. II. Determine the toxic effects of this regimen in these
patients. III. Determine the pharmacokinetics of TOPO/TAX/CBDCA and whether TAX/CBDCA will
affect the pharmacokinetics of TOPO on day 1 as compared to TOPO administered alone on day
3. IV. Describe any clinical responses observed in these patients.
OUTLINE: This is a dose escalation study of the combination
topotecan/paclitaxel/carboplatin. Patients are stratified according to prior chemotherapy
and radiotherapy (yes vs no). Part I: Patients receive topotecan IV on days 1-3 and
paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes, on day 1. Part II:
Patients receive topotecan, paclitaxel, and carboplatin as in part I, plus filgrastim
(G-CSF) on days 6-19. Treatment repeats every 3 weeks in the absence of disease progression
or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of
topotecan/paclitaxel/carboplatin 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.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study within 4
years.
Interventional
Primary Purpose: Treatment
Corey J. Langer, MD
Study Chair
Fox Chase Cancer Center
United States: Federal Government
CDR0000064913
NCT00005021
July 1996
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |