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| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00024167 |
Purpose
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 |
|---|---|---|
|
Prostate Cancer |
Drug: Docetaxel Drug: Doxorubicin hydrochloride Drug: Estramustine phosphate sodium Drug: Ketoconazole Drug: Prednisone Drug: Vinblastine Radiation: Strontium chloride Sr 89 Drug: Dexamethasone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Prospective Randomized Phase III, Trial Comparing Consolidation Therapy With or Without Strontium-89 Following Induction Chemotherapy in Androgen-Independent Prostate Cancer |
| Estimated Enrollment: | 480 |
| Study Start Date: | October 2001 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Induction regimen A
Doxorubicin IV over 24 hours day 1; Oral ketoconazole 3 x daily on days 1-7 of weeks 1, 3, and 5; Vinblastine IV over 30 minutes Day 1, oral Estramustine 3 x daily on Days 1-7 of weeks 2, 4, and 6.
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Drug: Doxorubicin hydrochloride
20 mg/m2 IV, day 1 on Weeks 1, 3, 5
Other Names:
Drug: Estramustine phosphate sodium
140 mg orally 3 x days, Days 1 through 7 on Weeks 2, 4, 6
Other Name: Estramustine
Drug: Ketoconazole
400 mg orally (po) 3 x day, Days 1 through 7
Other Name: Nizoral
Drug: Vinblastine
4 mg/m2 IVPB, Day 1 on Weeks 2, 4, 6
Other Name: Velban
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Experimental: Induction regimen B
Oral Prednisone 2 x daily on days 1-21 (days 1-14 of course 5 only) and Docetaxel IV over 1 hour Day 1.
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Drug: Docetaxel
75 mg/m2 IVPB over 1 hour, Day 1, every 3 weeks.
Other Name: Taxotere
Drug: Prednisone
5 mg orally 2 x daily, weeks 1-14
Drug: Dexamethasone
4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
Other Name: Decadron
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Experimental: Consolidation arm I
Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
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Drug: Doxorubicin hydrochloride
20 mg/m2 IV, day 1 on Weeks 1, 3, 5
Other Names:
Radiation: Strontium chloride Sr 89
One dose (4 mCi total dose) IV
Other Names:
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Experimental: Consolidation arm II
Doxorubicin as in Consolidation arm I.
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Drug: Doxorubicin hydrochloride
20 mg/m2 IV, day 1 on Weeks 1, 3, 5
Other Names:
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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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Show 40 Study Locations| Study Chair: | Shi-Ming Tu, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00024167 History of Changes |
| Other Study ID Numbers: | ID00-156, U10CA045809, P30CA016672, MDA-ID-00156, NCI-3410, CDR0000068897 |
| Study First Received: | September 13, 2001 |
| Last Updated: | December 15, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer |
Strontium-89 Induction Chemotherapy Androgen-Independent Prostate Cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Androgens Dexamethasone acetate Dexamethasone Prednisone Dexamethasone 21-phosphate Estramustine Docetaxel Doxorubicin |
Vinblastine Sodium phosphate BB 1101 Ketoconazole Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antiemetics Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Gastrointestinal Agents |