Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
NCT ID: NCT00003084
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
75 participants
INTERVENTIONAL
1997-12-31
2002-11-30
Brief Summary
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PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy consisting of paclitaxel, etoposide, and estramustine as compared with ketoconazole plus doxorubicin, vinblastine, and estramustine in treating patients with prostate cancer.
Detailed Description
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OUTLINE: This is a randomized multicenter study. Patients are stratified according to risk group: low volume disease (no more than 2 lesions on bone scan), intermediate volume (more than 2 bone lesions confined to axial skeleton), or high volume (bone lesions in appendicular skeletal or visceral lesions). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral estramustine three times a day and oral etoposide twice daily on days 1-14 and paclitaxel IV over 1 hour on day 2. Treatment repeats every 21 days. Arm II: Patients receive doxorubicin IV on days 1, 15, and 29, vinblastine IV on days 8, 22, and 36, oral ketoconazole three times a day on days 1-7, 15-21, and 29-35, and oral estramustine three times a day on days 8-14, 22-28, and 36-42. This regimen consists of 6 weeks of alternating chemotherapy and 2 weeks rest, for an 8 week course. Treatment continues in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 92 patients (46 per treatment arm) will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I (Estramustine + Etoposide)
Arm I: Oral Estramustine 3 x day + oral Etoposide 2 x day on days 1-14 + Paclitaxel IV over 1 hour Day 2, repeats every 21 days.
Estramustine phosphate sodium
Arm I: Oral estramustine three times a day for 21 day cycle.
Arm II: Oral estramustine three times a day on days 8-14, 22-28, and 36-42 in 8 week cycle.
Etoposide
Oral etoposide twice daily on days 1-14.
Paclitaxel
IV over 1 hour on day 2.
Arm II (Chemotherapy + Ketoconazole)
Arm II: Doxorubicin IV Days 1, 15, and 29, Vinblastine IV Days 8, 22, and 36, Oral Ketoconazole 3 x day on Days 1-7, 15-21, + 29-35, and Oral Estramustine 3 x day on Days 8-14, 22-28, and 36-42; 6 weeks of alternating chemotherapy and 2 weeks rest, for 8 week course.
Doxorubicin Hydrochloride
Doxorubicin IV on days 1, 15, and 29.
Estramustine phosphate sodium
Arm I: Oral estramustine three times a day for 21 day cycle.
Arm II: Oral estramustine three times a day on days 8-14, 22-28, and 36-42 in 8 week cycle.
Ketoconazole
Oral ketoconazole three times a day on days 1-7, 15-21, and 29-35.
Vinblastine
IV on days 8, 22, and 36.
Interventions
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Doxorubicin Hydrochloride
Doxorubicin IV on days 1, 15, and 29.
Estramustine phosphate sodium
Arm I: Oral estramustine three times a day for 21 day cycle.
Arm II: Oral estramustine three times a day on days 8-14, 22-28, and 36-42 in 8 week cycle.
Etoposide
Oral etoposide twice daily on days 1-14.
Ketoconazole
Oral ketoconazole three times a day on days 1-7, 15-21, and 29-35.
Paclitaxel
IV over 1 hour on day 2.
Vinblastine
IV on days 8, 22, and 36.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-3 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.5 g/dL (without transfusion support) Hepatic: Bilirubin and transaminase less than 2 times the upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL OR Estimated creatinine clearance at least 35 mL/min Cardiovascular: No clinical history of heart disease Normal ECG OR Ejection fraction (ECHO, MUGA, or ventriculography) at least 45% Other: Spinal cord compression controlled No active peptic ulcer disease No active, or likely to become active, second malignancy
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior ketoconazole Chemotherapy: No prior doxorubicin, vinblastine, estramustine, paclitaxel, or etoposide No greater than one prior cytotoxic therapy No other concurrent chemotherapy At least 8 weeks since prior mitomycin At least 60 days since prior suramin Endocrine therapy: No antiandrogen therapy such as flutamide or nilutamide within 4 weeks (6 weeks for bicalutamide) without response OR Progression since antiandrogen withdrawal Prior dexamethasone therapy discontinued Radiotherapy: At least 10 weeks since prior strontium Sr 89 and no more than 1 prior regimen No concurrent strontium Sr 89 Surgery: Not specified Other: No other concurrent therapy for prostate cancer No concurrent H2 blockers, omeprazole, or antacids No concurrent terfenadine and astemizole
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Randall E. Millikan, MD, PhD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Millikan R, Thall PF, Lee SJ, Jones D, Cannon MW, Kuebler JP, Wade J 3rd, Logothetis CJ. Randomized, multicenter, phase II trial of two multicomponent regimens in androgen-independent prostate cancer. J Clin Oncol. 2003 Mar 1;21(5):878-83. doi: 10.1200/JCO.2003.04.057.
Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-DM-97022
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-T97-0023
Identifier Type: -
Identifier Source: secondary_id
CDR0000065783
Identifier Type: REGISTRY
Identifier Source: secondary_id
DM97-022
Identifier Type: -
Identifier Source: org_study_id