Combination Chemotherapy in Treating Patients With Germ Cell Tumors That Have Not Responded to Previous Cisplatin

Memorial Sloan Kettering Cancer Center43 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Ovarian Cancer Testicular Germ Cell Tumor

Interventions

filgrastimBIOLOGICAL

cisplatinDRUG

ifosfamideDRUG

paclitaxelDRUG

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen * Active disease meeting 1 of the following conditions: * Measurable or evaluable disease * Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin) * Unresectable residual disease after postchemotherapy surgery * Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following: * No more than 1 prior regimen or 6 prior courses of cisplatin * Testis or ovarian germ cell primary site * Prior CR to cisplatin therapy * Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin PATIENT CHARACTERISTICS: Age: * 15 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 8.0 g/dL Hepatic: * Not specified Renal: * Creatinine clearance greater than 50 mL/min * Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator Cardiovascular: * If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry Other: * No active infection not well controlled on antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * No prior paclitaxel or ifosfamide * At least 3 weeks since prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * See Disease Characteristics * Recovered from recent surgery

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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