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CCI-779 in Treating Patients With Prostate Cancer

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. Identifier: NCT00012142
Recruitment Status : Completed
First Posted : March 26, 2004
Last Update Posted : June 24, 2013
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 3, 2001
First Posted Date  ICMJE March 26, 2004
Last Update Posted Date June 24, 2013
Study Start Date  ICMJE September 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE CCI-779 in Treating Patients With Prostate Cancer
Official Title  ICMJE Randomized, Double-Blind, Placebo-Controlled, Phase II Study Of Intravenous CCI-779 Administered Weekly To Patients With Androgen-Independent Prostate Cancer
Brief Summary

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.

Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: temsirolimus
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00012142
Other Study ID Numbers  ICMJE CDR0000068487
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Diane Prager, MD Jonsson Comprehensive Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date May 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP