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

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage I prostate cancer
Eligibility Criteria
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
Sites / Locations
- Jonsson Comprehensive Cancer Center at UCLA