Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-28 @ 1:05 PM
Study NCT ID:
NCT00003259
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vinorelbine in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '1999-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-24', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-07-30', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-09', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '12142053', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy.', 'detailedDescription': '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.\n\nOUTLINE: 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.\n\nPROJECTED ACCRUAL: A total of 14-40 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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\n\nPATIENT 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\n\nPRIOR 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'}, 'identificationModule': {'nctId': 'NCT00003259', 'briefTitle': 'Vinorelbine in Treating Patients With Metastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Swiss Cancer Institute'}, 'officialTitle': 'Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4: Vinorelbine', 'orgStudyIdInfo': {'id': 'SAKK 08/97'}, 'secondaryIdInfos': [{'id': 'SWS-SAKK-08/97'}, {'id': 'EU-97042'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'vinorelbine tartrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '5001', 'city': 'Aarau', 'country': 'Switzerland', 'facility': 'Kantonspital Aarau', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': 'CH 4051', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Office of Walter Weber-Stadelman', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH-4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': 'CH-1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Hopital Cantonal Universitaire de Geneva', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': 'CH-6900', 'city': 'Lugano', 'country': 'Switzerland', 'facility': 'Istituto Oncologico della Svizzera Italiana', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': 'CH-9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital - Saint Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '4500', 'city': 'Solothurn', 'country': 'Switzerland', 'facility': 'Burgerspital, Solothurn', 'geoPoint': {'lat': 47.20791, 'lon': 7.53714}}, {'zip': '8063', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'City Hospital Triemli', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'CH-8008', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Klinik Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Rudolf Morant, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Cantonal Hospital of St. Gallen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Swiss Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}