Expired Study
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New York, New York 10021


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00002559


Primary Contact:

Study Chair
Robert J. Motzer, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10021
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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