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

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Treatments: Cisplatin; Ifosfamide; Isophosphamide mustard; Paclitaxel

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