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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00024167 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radioactive substances such as strontium-89 may relieve bone pain associated with prostate cancer. It is not yet known whether chemotherapy is more effective with or without strontium-89 in treating bone metastases.
PURPOSE: This randomized phase III trial is studying giving chemotherapy together with strontium-89 to see how well it works compared to chemotherapy alone in treating patients with prostate cancer that has spread to the bone.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: docetaxel Drug: doxorubicin hydrochloride Drug: estramustine phosphate sodium Drug: ketoconazole Drug: prednisone Drug: vinblastine Radiation: strontium chloride Sr 89 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Stronium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer |
Estimated Enrollment: | 480 |
Study Start Date: | October 2001 |
Estimated Primary Completion Date: | August 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Induction regimen A: Experimental
Patients receive doxorubicin IV over 24 hours on day 1 and oral ketoconazole three times daily on days 1-7 of weeks 1, 3, and 5. Patients receive vinblastine IV over 30 minutes on day 1 and oral estramustine three times daily on days 1-7 of weeks 2, 4, and 6. Treatment repeats every 8 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients continue to receive oral ketoconazole three times daily until disease progression
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Drug: doxorubicin hydrochloride
Given IV
Drug: estramustine phosphate sodium
Given orally
Drug: ketoconazole
Given orally
Drug: vinblastine
Given IV
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Induction regimen B: Experimental
Patients receive oral prednisone twice daily on days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity. |
Drug: docetaxel
Given IV
Drug: prednisone
Given orally
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Consolidation arm I: Experimental
Patients receive doxorubicin IV over 24 hours once weekly for 6 weeks plus strontium chloride Sr 89 IV once at the beginning of chemotherapy.
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Drug: doxorubicin hydrochloride
Given IV
Radiation: strontium chloride Sr 89
Given IV
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Consolidation arm II: Experimental
Patients receive doxorubicin as in consolidation arm I.
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Drug: doxorubicin hydrochloride
Given IV
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OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to type of induction chemotherapy (KAVE vs prednisone and docetaxel), number of bony metastases (no more than 20 vs more than 20), ECOG performance status (0-1 vs 2-3), and use of zoledronate (yes vs no).
Induction therapy: Patients receive 1 of 2 induction therapy regimens.
Treatment repeats every 8 weeks for at least 2 courses* in the absence of disease progression or unacceptable toxicity. NOTE: *Patients continue to receive oral ketoconazole three times daily until disease progression.
Regimen B (prednisone and docetaxel): Patients receive oral prednisone twice daily on days 1-21 (days 1-14 of course 5 only) and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for at least 5 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Approximately 480 patients (240 randomized) will be accrued for this study within 48 months.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of adenocarcinoma of the prostate
Androgen-independent
No evidence of response after either of the following anti-androgen withdrawal periods:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Shi-Ming Tu, MD | M.D. Anderson Cancer Center |
Responsible Party: | University of Texas M.D. Anderson CCOP Research Base ( Michael J. Fisch ) |
Study ID Numbers: | CDR0000068897, MDA-ID-00156, NCI-3410 |
Study First Received: | September 13, 2001 |
Last Updated: | August 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00024167 History of Changes |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Prostatic Diseases Genital Neoplasms, Male Hormone Antagonists Estramustine Hormones, Hormone Substitutes, and Hormone Antagonists Vinblastine Urogenital Neoplasms Hormones Docetaxel Anti-Bacterial Agents Antifungal Agents |
Alkylating Agents Antineoplastic Agents, Hormonal Antimitotic Agents Ketoconazole Genital Diseases, Male Glucocorticoids Doxorubicin Recurrence Tubulin Modulators Antineoplastic Agents, Alkylating Adenocarcinoma Antineoplastic Agents, Phytogenic Prostatic Neoplasms Androgens |
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Prostatic Diseases Genital Neoplasms, Male Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Estramustine Hormones, Hormone Substitutes, and Hormone Antagonists Vinblastine Urogenital Neoplasms Antibiotics, Antineoplastic Hormones Neoplasms by Site |
Therapeutic Uses Antifungal Agents Alkylating Agents Antineoplastic Agents, Hormonal Mitosis Modulators Antimitotic Agents Ketoconazole Genital Diseases, Male Glucocorticoids Doxorubicin Pharmacologic Actions Neoplasms Tubulin Modulators Antineoplastic Agents, Alkylating Antineoplastic Agents, Phytogenic |