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Neoadjuvant CCI-779 Followed By Radical Prostatectomy in Treating Patients With Newly Diagnosed Prostate Cancer Who Have a High Risk of Relapse

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: NCT00071968
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : January 8, 2013
National Cancer Institute (NCI)
Information provided by:
Jonsson Comprehensive Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as CCI-779, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving CCI-779 before surgery may shrink the tumor so that it can be removed.

PURPOSE: This randomized phase II trial is studying how well CCI-779 works in treating patients who are undergoing radical prostatectomy for newly diagnosed prostate cancer at high risk of relapse.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: temsirolimus Procedure: conventional surgery Procedure: neoadjuvant therapy Phase 2

Detailed Description:



  • Determine the effects of oral CCI-779 on changes in the phosphorylation state of proteins in the mammalian target of rapamycin (mTOR) signaling pathway in the tumor tissue of patients with newly diagnosed prostate cancer undergoing radical prostatectomy.
  • Determine the effects of this drug on changes in p70S6 kinase activity, phosphorylation state of mTOR pathway proteins, and on global and targeted gene expression patterns in the peripheral blood mononuclear cells (PBMCs) of these patients.


  • Determine the effects of this drug on global and targeted gene expression patterns in these patients.
  • Identify pharmacodynamic/pharmacogenomic surrogate markers of this drug in both tumor tissue and PBMCs and determine if blood may be used as a surrogate tissue source for biomarkers of drug activity in the tumor in these patients.
  • Determine, preliminarily, the potential antitumor effects of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Correlate phosphatase and tensin homolog (PTEN) gene status with the pharmacodynamic/pharmacogenomic effects of this drug in these patients.
  • Determine the effects of this drug on changes in protein expression patterns in the plasma of these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients randomized to arm III are stratified according to tumor expression of phosphatase and tensin homolog (PTEN) gene mutations (negative vs positive).

  • Arm I: Patients receive oral CCI-779 once daily for a total of 8 weeks.
  • Arm II: Patients receive a higher dose of CCI-779 as in arm I.
  • Arm III: Patients receive a higher dose (higher than arm II) of CCI-779 as in arm I.

Approximately 24-48 hours after the last dose of CCI-779, patients in all arms undergo radical prostatectomy.

Patients are followed on day 7-10 and then at 4 weeks after study completion.

PROJECTED ACCRUAL: A total of 40 patients (5 each for arms I and II and 30 for arm III) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Study Of Exploratory Pharmacogenomics And Pharmacologic Effects Of Neoadjuvant Oral CCI-779 In Newly Diagnosed Prostate Cancer Patients Undergoing Radical Prostatectomy Who Have A High Risk Of Relapse
Study Start Date : August 2003
Actual Primary Completion Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Primary Outcome Measures :
  1. Phosphorylation state of proteins
  2. p70S6 kinase activity
  3. Phosphorylation state of mTOR pathway proteins
  4. Global and targeted gene expression patterns in peripheral blood mononuclear cells

Secondary Outcome Measures :
  1. Global and targeted gene expression patterns
  2. Pharmacodynamics and pharmacogenomic surrogate markers
  3. Antitumor effects
  4. Pharmacokinetics
  5. Correlation of phosphatase and tensin homolog gene status with pharmacodynamic and pharmacogenomic effects
  6. Protein expression patterns in the plasma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically confirmed adenocarcinoma of the prostate

    • Diagnosis based on a minimum of 6 core biopsy samples
    • Clinically confirmed organ-confined disease
  • Candidate for radical prostatectomy
  • No evidence of metastatic disease by CT scan and bone scan
  • High risk of relapse based on either of the following criteria:

    • Any one of the following:

      • Stage T2C or higher
      • Gleason score greater than 7
      • Prostate-specific antigen (PSA) greater than 20 ng/mL OR
    • Any two of the following:

      • Gleason score at least 7
      • PSA 10-20 ng/mL
      • Greater than 50% of total biopsy cores with cancer involvement



  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • No active bleeding
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • No acute or chronic hepatitis B

    • Hepatitis B surface antigen negative
  • No acute or chronic hepatitis C

    • No antibodies to hepatitis C
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2 times ULN


  • No ongoing urinary tract infection necessitating rapid or emergent surgical resection
  • Creatinine no greater than 1.5 times ULN


  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy


  • No known pulmonary hypertension
  • No pneumonitis


  • Fertile patients must use effective contraception during and for 12 weeks after study participation
  • HIV negative
  • No other severe immunocompromised states
  • No active infection requiring antibiotic therapy
  • No serious concurrent illness
  • No other major illness that would substantially increase the risk associated with study participation
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer


Biologic therapy

  • No concurrent immunotherapy


  • No prior chemotherapy
  • No other concurrent chemotherapy

Endocrine therapy

  • More than 3 weeks since prior IV corticosteroids
  • No concurrent systemic corticosteroids
  • No prior or concurrent hormonal therapy for underlying malignancy


  • No prior or concurrent radiotherapy


  • More than 3 months since prior major surgery


  • More than 1 month since prior experimental drugs
  • More than 3 weeks since prior immunosuppressive agents
  • No concurrent immunosuppressive therapies
  • No other concurrent investigational agents
  • No concurrent enzyme-inducing anticonvulsants (e.g., phenobarbital, phenytoin, or carbamazepine)
  • No concurrent ketoconazole, diltiazem, rifampin, terfenadine, cisapride, astemizole, pimozide, or Hypericum perforatum (St. John's wort)
  • No concurrent grapefruit or grapefruit juice

Information from the National Library of Medicine

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 identifier (NCT number): NCT00071968

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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1738
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Charles Sawyers, MD Jonsson Comprehensive Cancer Center
Publications of Results:
Thomas G, Speicher L, Reiter R, et al.: Demonstration that temsirolimus preferentially inhibits the mTOR pathway in the tumors of prostate cancer patients with PTEN deficiencies. [Abstract] Clin Cancer Res 11 (Suppl 24): A-C131, 2005.

Layout table for additonal information Identifier: NCT00071968    
Other Study ID Numbers: CDR0000331979
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: January 8, 2013
Last Verified: January 2013
Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the prostate
stage IIB prostate cancer
stage IIA prostate cancer
stage I prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs