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Vinorelbine in Treating Patients With Metastatic Prostate Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00003259
First received: November 1, 1999
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
 Drug: vinorelbine tartrate
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Swiss Group for Clinical Cancer Research:

Estimated Enrollment: 40
Study Start Date: October 1997
Study Completion Date: September 1999
Primary Completion Date: September 1999 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer. II. Evaluate the toxicity of vinorelbine in these patients. III. Evaluate the quality of life of these patients, and correlate quality of life with PSA response.

OUTLINE: Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course. Patients with stabilization of their disease, partial response, or complete response, receive a maximum of 12 courses of treatment. Patients showing disease progression or severe toxic side effects discontinue treatment. Quality of life and pain are assessed prior to treatment, at days 1 and 8 of each course, and at end of the treatment. Patients are followed every 3 months until disease progression.

PROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003259

Locations
Switzerland
Kantonspital Aarau
Aarau, Switzerland, 5001
University Hospital
Basel, Switzerland, CH-4031
Office of Walter Weber-Stadelman
Basel, Switzerland, CH 4051
Inselspital, Bern
Bern, Switzerland, CH-3010
Hopital Cantonal Universitaire de Geneva
Geneva, Switzerland, CH-1211
Istituto Oncologico della Svizzera Italiana
Lugano, Switzerland, CH-6900
Kantonsspital - Saint Gallen
Saint Gallen, Switzerland, CH-9007
Burgerspital, Solothurn
Solothurn, Switzerland, 4500
Klinik Hirslanden
Zurich, Switzerland, CH-8008
City Hospital Triemli
Zurich, Switzerland, 8063
Sponsors and Collaborators
Swiss Group for Clinical Cancer Research
Investigators
Study Chair: Rudolf Morant, MD Kantonsspital St. Gallen
  More Information

No publications provided

Responsible Party: Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier: NCT00003259     History of Changes
Other Study ID Numbers: SAKK 08/97, SWS-SAKK-08/97, EU-97042
Study First Received: November 1, 1999
Last Updated: May 14, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by Swiss Group for Clinical Cancer Research:
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Vinorelbine
Vinblastine
 Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013