Overview

Vinorelbine in Treating Patients With Metastatic Prostate Cancer

Status:
Completed
Trial end date:
1999-09-01
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. PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Swiss Group for Clinical Cancer Research
Treatments:
Vinblastine
Vinorelbine
Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic stage IV
prostate cancer Proven hormonal resistance Measurable or evaluable disease PSA at least 3
times upper limit of normal No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS: Age: 18 to 85 Performance status: WHO 0-2 Life expectancy: Greater
than 12 weeks Hematopoietic: WBC at least 3500/mm3 OR Granulocyte count at least 2000/mm3
Hemoglobin at least 9 g/dL Platelet count at least 100,000/mm3 Hepatic: Bilirubin no
greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN
Renal: Creatinine no greater than 1.5 times ULN Other: No acute severe infections No other
neoplastic diseases except curatively treated basal cell or squamous cell carcinoma of the
skin, or relapse free for more than 5 years after curative treatment of a neoplasm

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior cytostatic
chemotherapy Endocrine therapy: At least 1 month since antiandrogens Prior hormonal therapy
required Radiotherapy: No radiotherapy within the past 4 weeks No radiotherapy to the
lesions used to evaluate activity of the study drug Surgery: Prior orchiectomy allowed
Other: No other investigational drugs during the last month No prior therapy with
cytostatic agents