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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Sirolimus

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