PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
- Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and
ifosfamide in patients with germ cell tumors with favorable prognostic features and
resistance to cisplatin.
- Determine the efficacy of this regimen as salvage therapy in these patients.
OUTLINE: This is a dose escalation study of paclitaxel.
Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and
ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously
(SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4
courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6
patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the
After completion of chemotherapy, some patients may undergo resection of residual masses.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Robert J. Motzer, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|