Ovarian Cancer Clinical Trial
Official title:
PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy consisting
of paclitaxel, cisplatin, and ifosfamide in treating patients who have ovarian or testicular
germ cell tumors that are refractory to platinum-containing chemotherapy.
OBJECTIVES:
- 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
MTD.
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
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