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Brief Title † | Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy | ||||||||||||
Official Title † | 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 † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Active Control | ||||||||||||
Primary Outcome Measure † | |||||||||||||
Secondary Outcome Measure † | |||||||||||||
Condition † | Prostate Cancer | ||||||||||||
Intervention † | Drug: docetaxel Drug: estramustine phosphate sodium Drug: mitoxantrone hydrochloride Drug: prednisone |
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MEDLINE PMIDs | 19130298, 16622120, 16782921, 15470214, 10604271, 18307687, 17007996, 17956560, 17387372, 17868721, 16631461, 17084173, 16904054, 16266195 | ||||||||||||
Links | Clinical trial summary from the National Cancer Institute's PDQ® database  | ||||||||||||
Recruitment Information Fields | |||||||||||||
Recruitment Status † | Active, not recruiting | ||||||||||||
Enrollment † | 620 | ||||||||||||
Start Date † | October 1999 | ||||||||||||
Completion Date | |||||||||||||
Eligibility Criteria † | 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 †† | |||||||||||||
Location Countries † | United States | ||||||||||||
Administrative Information Fields | |||||||||||||
NCT ID † | NCT00004001 | ||||||||||||
Organization ID | CDR0000067211 | ||||||||||||
Secondary IDs †† | SWOG-S9916, CLB-99808, NCCTG-S9916 | ||||||||||||
Study Sponsor † | Southwest Oncology Group | ||||||||||||
Collaborators †† | National Cancer Institute (NCI) Cancer and Leukemia Group B North Central Cancer Treatment Group |
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Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||||||
Verification Date | May 2003 | ||||||||||||
First Received Date † | November 1, 1999 | ||||||||||||
Last Updated Date | January 13, 2009 |