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Status:

COMPLETED

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

Lead Sponsor:

Jonsson Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Prostate Cancer

Eligibility:

MALE

18+ years

Phase:

PHASE2

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...

Detailed Description

OBJECTIVES: Primary * 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 p...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • 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
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • ECOG 0-1
  • Life expectancy
  • Not specified
  • Hematopoietic
  • 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
  • Hepatic
  • 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
  • Renal
  • No ongoing urinary tract infection necessitating rapid or emergent surgical resection
  • Creatinine no greater than 1.5 times ULN
  • Cardiovascular
  • No unstable angina
  • No myocardial infarction within the past 6 months
  • No life-threatening ventricular arrhythmia requiring ongoing maintenance therapy
  • Pulmonary
  • No known pulmonary hypertension
  • No pneumonitis
  • Other
  • 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
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No concurrent immunotherapy
  • Chemotherapy
  • 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
  • Radiotherapy
  • No prior or concurrent radiotherapy
  • Surgery
  • More than 3 months since prior major surgery
  • Other
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    15 Patients enrolled

    Trial Details

    Trial ID

    NCT00071968

    Start Date

    August 1 2003

    Last Update

    January 8 2013

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Jonsson Comprehensive Cancer Center at UCLA

    Los Angeles, California, United States, 90095-1738