Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

• 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.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

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

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Hormones; Mitoxantrone; Vinorelbine

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed stage IV hormone refractory adenocarcinoma of the prostate

• Progressive disease despite hormonal therapy or orchiectomy

• No brain metastases

PATIENT CHARACTERISTICS:

Age:

• 18 to 80

Performance status:

• WHO 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Absolute neutrophil count at least 2,000/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 9 g/dL

Hepatic:

• Alkaline phosphatase no greater than 2 times upper limit of normal (ULN) (unless bone metastasis)

• Bilirubin less than 2 times ULN

Renal:

• Creatinine less than 2 times ULN

Cardiovascular:

• Adequate cardiac function

Other:

• No other prior malignancy except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• See Disease Characteristics

• Prior corticosteroids allowed if started at least 8 weeks prior to study

Radiotherapy:

• At least 8 weeks since prior extensive radiotherapy

Surgery:

• See Disease Characteristics