Vinorelbine in Treating Patients With Metastatic Prostate Cancer
NCT ID: NCT00003259
Last Updated: 2019-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
1997-10-31
1999-09-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.
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Detailed Description
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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.
Conditions
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Study Design
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TREATMENT
Interventions
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vinorelbine tartrate
Eligibility Criteria
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Inclusion Criteria
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
18 Years
85 Years
MALE
No
Sponsors
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Swiss Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Rudolf Morant, MD
Role: STUDY_CHAIR
Cantonal Hospital of St. Gallen
Locations
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Kantonspital Aarau
Aarau, , Switzerland
Office of Walter Weber-Stadelman
Basel, , Switzerland
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Hopital Cantonal Universitaire de Geneva
Geneva, , Switzerland
Istituto Oncologico della Svizzera Italiana
Lugano, , Switzerland
Kantonsspital - Saint Gallen
Sankt Gallen, , Switzerland
Burgerspital, Solothurn
Solothurn, , Switzerland
City Hospital Triemli
Zurich, , Switzerland
Klinik Hirslanden
Zurich, , Switzerland
Countries
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References
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Morant R, Hsu Schmitz SF, Bernhard J, Thurlimann B, Borner M, Wernli M, Egli F, Forrer P, Streit A, Jacky E, Hanselmann S, Bauer J, Hering F, Schmid HP. Vinorelbine in androgen-independent metastatic prostatic carcinoma--a phase II study. Eur J Cancer. 2002 Aug;38(12):1626-32. doi: 10.1016/s0959-8049(02)00145-4.
Other Identifiers
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SWS-SAKK-08/97
Identifier Type: -
Identifier Source: secondary_id
EU-97042
Identifier Type: -
Identifier Source: secondary_id
SAKK 08/97
Identifier Type: -
Identifier Source: org_study_id
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