Combination Chemotherapy in Treating Male Patients With Germ Cell Tumors

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, vincristine, bleomycin, carboplatin, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating germ cell tumors.

PURPOSE: This randomized phase II trial is studying two different combination chemotherapy regimens to compare how well they work in treating male patients with germ cell tumors.

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

Details

• Lead Sponsor: Medical Research Council
• Treatments: Bleomycin; Carboplatin; Etoposide; Etoposide phosphate; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Nonseminoma germ cell tumor of any extracranial primary site diagnosed by 1 of the following methods:

• Histologic confirmation

• Alpha-fetoprotein (AFP) > 1,000 ng/mL or human chorionic gonadotropin (hCG) > 5,000 IU/L with appropriate clinical picture in a man < 45 years of age

• Poor prognosis features as defined by ≥ 1 of the following:

• AFP > 10,000 ng/mL

• hCG > 50,000 IU/L

• Lactic dehydrogenase > 10 times normal

• Nonpulmonary visceral metastases

• Mediastinal primary site

PATIENT CHARACTERISTICS:

• Male

• WHO performance status 0-3

• Glomerular filtration rate > 50 mL/min

• Less than 50 mL/min eligible if due to obstructive neuropathy that can be relieved by stenting or nephrostomy

• No comorbid condition that would prevent treatment

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

• No prior chemotherapy except low-dose chemotherapy to stabilize disease before study therapy