Sirolimus Before Surgery in Treating Patients With Advanced Localized Prostate Cancer

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

Summary

RATIONALE: Drugs used in chemotherapy, such as sirolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This clinical trial is studying the best dose of sirolimus and to see how well it works before surgery in treating patients with advanced localized prostate cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Everolimus; Sirolimus

Criteria

DISEASE CHARACTERISTICS:

• Histologically determined adenocarcinoma of the prostate

• Stage T1c-T3b disease

• No evidence of disease that has spread beyond the prostate or seminal vesicles

• No metastatic prostate cancer, including bone, visceral, brain, and lymph node metastases

• Tumor Gleason score sum of 7-10 (4+3 and 3+4 allowed) with tumor involving at least 2 discrete core biopsy sections

• Scheduled to undergo radical prostatectomy

• No other subtypes of prostate cancer, including any of the following:

• Sarcoma

• Neuroendocrine tumors

• Small cell cancer

• Ductal cancer

• Lymphoma

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1

• WBC > 3,500/mm^3

• Absolute neutrophil count > 1,500/mm^3

• Platelet count > 100,000/mm^3

• Hemoglobin > 9 g/dL

• Creatinine < 2.0 mg/dL

• Bilirubin < 2 mg/dL

• ALT and AST < 2 times upper limit of normal (ULN)

• Alkaline phosphatase < 2 times ULN

• Triglycerides and total cholesterol < 2 times ULN

• No history of allergy to sirolimus (rapamycin) or its derivatives

• No uncontrolled medical condition that would increase risk or limit compliance with study requirements, including the following:

• Immunodeficiency

• Gastrointestinal disease that would limit ability to swallow, take oral medications, or absorb them

• No active infections

• No other concurrent malignancy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy, biologic therapy, radiotherapy, or immunotherapy for prostate cancer

• No concurrent chronic treatment with immunosuppressants or medications that interfere with the metabolism of sirolimus (rapamycin)

• No concurrent medication or agents that would interfere with the metabolism or excretion of rapamycin or its derivatives, including any of the following:

• Phenytoin

• Carbamazepine

• Cyclosporine

• Clarithromycin

• Clotrimazole

• Erythromycin

• Amiodarone

• Protease inhibitors used to treated HIV infection

• Cisapride

• Grapefruit juice

• Diltiazem

• Tacrolimus

• Hypericum perforatum (St. John's wort)

• Barbiturates

• Rifampin

• Phenobarbital

• Rifabutin

• Efavirenz

• Nevirapine

• At least 7 days since prior herbal medicines and medications, including any of the following:

• Hydrastis canadensis (goldenseal)

• Uncaria tomentosa (cat's claw)

• Echinacea angustifolia roots

• Trifolium pretense (wild cherry)

• Chamomile

• Glycyrrhiza glabra (licorice)

• Dillapiol

• Naringenin

• Norfloxacin

• Atorvastatin

• Pravastatin

• Cimetidine

• Fluconazole