CCI-779 in Treating Patients With Prostate Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00012142 |
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Recruitment Status :
Completed
First Posted : March 26, 2004
Last Update Posted : June 24, 2013
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Drug: temsirolimus | Phase 2 |
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.
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.
| Study Type : | Interventional (Clinical Trial) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled, Phase II Study Of Intravenous CCI-779 Administered Weekly To Patients With Androgen-Independent Prostate Cancer |
| Study Start Date : | September 2000 |
| Actual Study Completion Date : | March 2004 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
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
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00012142
| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Study Chair: | Diane Prager, MD | Jonsson Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00012142 History of Changes |
| Other Study ID Numbers: |
CDR0000068487 UCLA-000606401 GENE-C9940-32 UCLA-CCI-779 W-AR-3066K1-201-US NCI-G01-1917 |
| First Posted: | March 26, 2004 Key Record Dates |
| Last Update Posted: | June 24, 2013 |
| Last Verified: | May 2002 |
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stage IV prostate cancer |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Sirolimus Everolimus |
Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents Anti-Infective Agents Antibiotics, Antineoplastic Antifungal Agents |