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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES

Conditions
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Ovarian Cancer, Testicular Germ Cell Tumor

Intervention / Treatment
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* Biological: filgrastim
* Drug: cisplatin
* Drug: ifosfamide
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: filgrastim|nan|
|Drug: cisplatin|nan|
|Drug: ifosfamide|nan|
|Drug: paclitaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent malignant testicular germ cell tumor, recurrent ovarian germ cell tumor