Combination Chemotherapy in Treating Men With Germ Cell Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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. It is not yet known which regimen of combination chemotherapy may be more effective for germ cell cancer.

PURPOSE: This randomized phase II/III trial is studying two different regimens of combination chemotherapy and comparing how well they work in treating men with germ cell cancer.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
• Treatments: Albumin-Bound Paclitaxel; Bleomycin; Etoposide; Paclitaxel

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven germ cell cancer

• Seminoma

• Non-seminoma

• Combined

• Intermediate prognosis

• Non-seminoma:

• Testis/retroperitoneal primary

• No non-pulmonary visceral metastases

• Meets 1 of the following criteria:

• Alpha-fetoprotein (AFP) 1,000- 10,000 IU/L

• Human chorionic gonadotropin (hCG) 5,000-50,000 IU/L

• Lactic dehydrogenase (LDH) 1.5 times-10 times upper limit of normal (ULN)

• Seminoma:

• Any primary site

• Any LDH and HCG

• AFP normal

• Non-pulmonary visceral metastases present

PATIENT CHARACTERISTICS:

Age:

• 16 to 50

Sex:

• Male

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,000/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.25 times ULN

• AST no greater than 2 times ULN

Renal:

• Creatinine clearance at least 40 mL/min (unless due to obstructive uropathy which can be relieved by nephrostomy)

Other:

• No pre-existing neuropathy

• No other malignancy except basal cell skin cancer

• No other serious illness or medical conditions incompatible with the protocol

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified