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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1
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1738