Prostate Cancer Clinical Trial
Official title:
Temsirolimus, an mTOR Inhibitor, to Reverse Androgen Insensitivity in Patients With Castration-resistant Prostate Cancer
This study evaluates if temsirolimus causes a reduction in the serum levels of prostate-specific antigen (PSA) in male subjects with castration-resistant prostate cancer (CRPC).
Status | Terminated |
Enrollment | 5 |
Est. completion date | April 2012 |
Est. primary completion date | April 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
INCLUSION CRITERIA - Histologically-confirmed adenocarcinoma of the prostate, characterized as symptomatic castration-resistant prostate cancer (CRPC) - Serum PSA = 2 ng/mL - Rising PSA on 3 consecutive occasions at least 1 week apart (not limited to the 30-day screening period) - Failure of bilateral orchiectomy and/or therapy with an LHRH agonist and bicalutamide - Castrate level of testosterone (< 50 ng/dL) - Currently being treated with bicalutamide - No prior antiandrogen therapy except bicalutamide - Age = 18 years - Life expectancy > 6 months - Performance status - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - OR - Karnofsky performance status = 80% - Ability to understand and the willingness to sign a written informed consent EXCLUSION CRITERIA - Radiotherapy for prostate cancer within 28 days prior to Day 1, except single-fraction radiotherapy for pain control - Prior treatment with mTOR inhibitors - Prior treatment with chemotherapy for prostate cancer - Symptomatic bone metastases (ie, asymptomatic bone metastases are eligible) - Visceral metastases - Absolute neutrophil count (ANC) < 1500/uL - Platelet count = 100 x 10e9/L - Total bilirubin = 1.5 x Upper Limit of Normal (ULN) - Alkaline phosphatase > 2.5 x ULN - AST > 2.5 x ULN - ALT > 2. 5x ULN - Serum creatinine > 2.0 mg/dL - Hemoglobin < 9 g/dL - Men with reproductive potential who do not agree to use an accepted and effective method of contraception during the study treatment period and for at least 3 months after completion of the study treatment - History of other malignancies within 5 years except for tumors with a negligible risk for metastasis or death, such as adequately-controlled basal cell carcinoma, squamous-cell carcinoma of the skin, or early-stage bladder cancer - Participation in another experimental drug study either planned or within 4 weeks of the first study treatment - Persistent Grade = 1 AEs due to prior drug therapy, including investigational drugs, administered more than 14 days before study enrollment - Previously treated or other known brain metastases - Ongoing or active infection - Symptomatic congestive heart failure, New York Heart Association Grade II or greater - Unstable angina pectoris - Cardiac arrhythmia - Significant vascular disease (eg, aortic aneurysm, aortic dissection) - Symptomatic peripheral vascular disease - Psychiatric illness/social situations that would limit compliance with study requirements - Other uncontrolled intercurrent illness - Known to be positive for the human immunodeficiency virus (HIV) infection and receiving antiretroviral therapies (HIV positive not requiring antiretroviral therapy iseligible if all other entry criteria are meet) - Inability to comply with study and/or follow-up procedures |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Stanford University School of Medicine | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Sandy Srinivas | American Society of Clinical Oncology, National Comprehensive Cancer Network, Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in Serum PSA | Proportion of subjects with > 50% drop in serum PSA as compared to baseline, assessed at 16 weeks | 12 weeks treatment, with primary outcome assessed at 16 weeks | No |
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