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Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer Clinical research trials and Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer. Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer  Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
For Condition: adenocarcinoma of the prostate,recurrent prostate cancer,stage 2 prostate cancer,stage 4 prostate cancer,stage 1 prostate cancer,stage 3 prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. 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.
Details: OBJECTIVES: I. Determine the clinical benefit of two combination chemotherapy regimens, paclitaxel, etoposide, and estramustine vs ketoconazole, doxorubicin, vinblastine, and estramustine in patients with androgen independent prostate cancer, as measured by prostate specific antigen (PSA)-based response rate, time to progression, and overall survival. II. Identify the most promising regimen to use in a phase III trial based on toxic effects, PSA-based response rates, and clinical benefit. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed adenocarcinoma of the prostate - Androgen independent disease progression; Castrate testosterone level of less than 40 ng/dL (if medically achieved, treatment must be maintained continuously); Prostate specific antigen (PSA) at least 4 ng/mL and rising on at least 2 consecutive measurements - No variant histologies such as ductal carcinoma (endometrioid or cribiform) or small cell carcinoma - Brain metastases controlled --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RandallMillikan, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Additional Information:
Study ID Numbers: CDR0000065783; MDA-DM-97022,NCI-T97-0023
Study Start Date: December 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003084
Other Adenocarcinoma Of The Prostate Studies:
1. Leuvectin Followed By Surgery in Treating Patients With Stage II or Stage III Prostate Cancer
2. Radiation Therapy in Treating Patients With Prostate Cancer
3. TG4010 in Treating Patients With Prostate Cancer
4. Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer
5. Radiation Therapy With or Without Bicalutamide and Goserelin in Treating Patients With Prostate Cancer
Related Studies:
Other adenocarcinoma of the prostate Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Combination Chemotherapy With Ketoconazole in Treating Patients With Prostate Cancer
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