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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | November 1, 1999 | ||||||||||||
| Last Updated Date | April 23, 2009 | ||||||||||||
| Start Date ICMJE | October 1999 | ||||||||||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||
| Change History | Complete list of historical versions of study NCT00004001 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy | ||||||||||||
| Official Title ICMJE | Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced, Hormone Refractory Prostate Cancer | ||||||||||||
| Brief Summary | RATIONALE: Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells. It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease status (measurable or evaluable disease progression vs rising PSA only), NCI Common Toxicity Criteria version 2.X pain scale (grade 2 or greater vs less than 2), and SWOG performance status (0-1 vs 2-3). Patients are randomized to one of two treatment arms.
Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression. Quality of life is assessed at baseline, after courses 4 and 8, and then at 1 year after randomization. Patients are followed every 6 months for 2 years and then annually for 1 year. PROJECTED ACCRUAL: A total of 620 patients (310 per arm) will be accrued for this study within 3.5 years. |
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| Study Phase | Phase III | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Randomized, Active Control | ||||||||||||
| Condition ICMJE | Prostate Cancer | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Estimated Enrollment ICMJE | 620 | ||||||||||||
| Completion Date | |||||||||||||
| Primary Completion Date | July 2006 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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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 ID ICMJE | NCT00004001 | ||||||||||||
| Responsible Party | |||||||||||||
| Study ID Numbers ICMJE | CDR0000067211, SWOG-S9916, CLB-99808, NCCTG-S9916 | ||||||||||||
| Study Sponsor ICMJE | Southwest Oncology Group | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||||||
| Verification Date | May 2003 | ||||||||||||
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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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