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

Date de début de l'étude : 1 août 2003

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