Status:
COMPLETED
Sirolimus Before Surgery in Treating Patients With Advanced Localized Prostate Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18-120 years
Phase:
PHASE1
PHASE2
Brief 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 clinic...
Detailed Description
OBJECTIVES: Primary * Determine the pharmacodynamically optimal dose (POD) of continuous daily oral sirolimus (rapamycin) in patients with advanced localized prostate cancer when given prior to radi...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00311623
Start Date
August 1 2006
End Date
June 1 2010
Last Update
February 22 2019
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231
2
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
3
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710