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CCI-779 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 by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on CCI-779 in Treating Patients With Prostate Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. CCI-779 in Treating Patients With Prostate Cancer Clinical research trials and CCI-779 in Treating Patients With Prostate Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including CCI-779 in Treating Patients With Prostate Cancer. CCI-779 in Treating Patients With Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a CCI-779 in Treating Patients With Prostate Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their CCI-779 in Treating Patients With Prostate Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > CCI-779 in Treating Patients With Prostate Cancer  CCI-779 in Treating Patients With Prostate Cancer
CCI-779 in Treating Patients With Prostate Cancer
For Condition: stage 4 prostate cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Jonsson Comprehensive Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to determine the effectiveness of CCI-779 in treating patients who have progressive prostate cancer.
Details: OBJECTIVES: I. Determine the safety of CCI-779 in patients with androgen-independent prostate cancer. II. Determine the effects of CCI-779 on prostate-specific antigen levels in these patients. III. Assess the pharmacokinetic parameters of CCI-779 in these patients. IV. Assess the possible pharmacodynamic relationship of CCI-779 with clinical response in these patients. V. Determine the impact of CCI-779 on the quality of life in these patients. PROTOCOL OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 4 arms. Arm I: Patients receive low-dose CCI-779 IV over 30 minutes weekly. Arm II: Patients receive high-dose CCI-779 IV over 30 minutes weekly. Arm III: Patients receive low-dose placebo IV over 30 minutes weekly. Arm IV: Patients receive high-dose placebo IV over 30 minutes weekly. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who develop progressive disease while receiving placebo may cross over to the equivalent dose of CCI-779. Quality of life is assessed at baseline; at weeks 4, 8, 12, 24, and 36; and at final/cross-over visit. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 150 patients 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 asymptomatic, progressive, metastatic adenocarcinoma of the prostate Progressive disease defined as increasing prostate-specific antigen (PSA) levels from 2 measurements at least 2 weeks apart - PSA greater than 5 ng/mL - Continued medical means of gonadal ablation (e.g., luteinizing hormone releasing hormone (LHRH)) required - No known CNS metastases unless previously treated by surgery or radiotherapy and stable, asymptomatic, and not requiring steroids and anticonvulsants --Prior/Concurrent Therapy-- - Biologic therapy: Concurrent epoetin alfa allowed - Chemotherapy: No prior cytotoxic chemotherapy for prostate cancer; No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics; At least 6 weeks since prior antiandrogen therapy; At least 4 weeks since prior hormonal therapy (6 weeks for antiandrogens) for prostate cancer other than continued LHRH agonist; No concurrent systemic corticosteroids; No concurrent anticancer hormonal therapy - Radiotherapy: At least 3 weeks since prior radiotherapy; No prior palliative radiotherapy to more than one site; No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium; No concurrent radiotherapy - Surgery: At least 3 weeks since prior surgery - Other: At least 4 weeks since prior investigational agent; No concurrent immunosuppressive agents; No other concurrent investigational agent; No concurrent enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoin), ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, or pimozide; No concurrent megestrol acetate for appetite; Concurrent bisphosphonates allowed --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 6 months - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 8.5 g/Dl - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); AST no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present); Serum cholesterol no greater than 350 mg/Dl; Triglycerides no greater than 300 mg/Dl - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No unstable angina or life-threatening ventricular arrhythmia requiring maintenance therapy; No myocardial infarction within the past 6 months - Other: No other malignancy in past 5 years other than basal cell or squamous cell skin cancer; HIV negative; No active infection; Not immunocompromised; No other major illness that would preclude study; Fertile patients must use effective contraception during and for 3 months after the study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DianePrager, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068487; W-AR-3066K1-201-US,UCLA-CCI-779,GENE-C9940-32,UCLA-000606401,NCI-G01-1917
Study Start Date: September 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012142
Other Stage 4 Prostate Cancer Studies:
1. 3-AP in Treating Patients With Advanced Prostate Cancer
2. Liposomal Doxorubicin and Thermal Therapy in Treating Patients With Prostate Cancer
3. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
4. Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
5. Chemotherapy, Hormone Therapy, and Radiation Therapy in Treating Patients with Locally Advanced Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
CCI-779 in Treating Patients With Prostate Cancer
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