Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 26, 2011 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00003622 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy | ||||
| Official Title ICMJE | Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer | ||||
| Brief 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 plus paclitaxel in treating patients with metastatic prostate cancer that is refractory to hormone therapy. |
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| Detailed Description | OBJECTIVES: I. Determine the clinical benefit response (including improvement in quality of life) of vinorelbine and paclitaxel in patients with metastatic hormone-refractory prostate cancer. II. Correlate PSA response with clinical benefit response in these patients. III. Determine the objective response rate and duration of remission in patients with measurable disease treated with this regimen. IV. Further assess the toxicity of this combination in a cohort of prostate cancer patients. V. Examine the survival characteristics of these patients undergoing this regimen. OUTLINE: This an open label study. Patients receive vinorelbine IV over 6-10 minutes on days 1, 2, and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine. Course repeats every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed before each treatment course. Patients are followed until death. PROJECTED ACCRUAL: A total of 30 patients will be accrued into this study over 15-30 months. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Primary Purpose: Treatment | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Completion Date | Not Provided | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically proven metastatic adenocarcinoma of the prostate that is hormone refractory Hormone-refractory defined as at least 50% increase in PSA while continuing hormonal therapy Must have received prior hormonal manipulation including either orchiectomy or LHRH agonist Must be symptomatic and on a stable dose of pain medication No documented CNS involvement PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 1-2 Life expectancy: At least 16 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Renal: Creatinine no greater than 1.8 mg/dL Other: Not HIV positive No concurrent infection No concurrent medical or psychiatric illness that precludes study compliance No prior or concurrent second malignancy in the past 5 years except basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior antiandrogens If patients have received prior antiandrogens, PSA levels are reassessed at 4 week intervals until there is no decrease in PSA levels before registration into this study Radiotherapy: Prior radiotherapy allowed Must have recovered from prior radiotherapy Concurrent radiotherapy for symptomatic bone lesion allowed Surgery: Not specified Other: No other concurrent therapeutic study |
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| Gender | Male | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00003622 | ||||
| Other Study ID Numbers ICMJE | CDR0000066701, GWCC-4097, GW-GWCC-4097, NCI-V98-1486 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | George Washington University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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