Status:
COMPLETED
RAD001 and Bicalutamide for Androgen Independent Prostate Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Beth Israel Deaconess Medical Center
Novartis Pharmaceuticals
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
In the treatment of castration-resistant prostate cancer (CRPC), therapies will long response durations remain elusive as a result of the inherent ability of prostate cancer cells to develop iterative...
Detailed Description
Bicalutamide, an androgen receptor (AR) antagonist, is frequently used as the first 'secondary hormonal therapy' in combination with another established agent (LHRH: luteinizing hormone-releasing horm...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Histologically documented prostate cancer
- Castration resistant prostate cancer defined as two rising PSAs on castration therapy
- Baseline PSA of 2ns/mL or greater
- Testosterone of 50ng/mL or less
- Patients on LHRH agonist/antagonist must continue therapy at the recommended dosing intervals
- Prior bicalutamide is allowed as long as treatment was for 6 months or longer
- Metastatic disease is not required
- Minimum of four weeks since any major surgery, completion of radiation, or completion of all prior systemic anticancer therapy
- ECOG Performance Status equal to or less than 2
- Adequate bone marrow and liver function as outlined by parameters in the protocol
Exclusion
- Prior treatment with any investigational drug within the preceding 4 weeks
- Prior treatment with an mTOR inhibitor
- Fasting lipids over the parameters outlined in the protocol
- Chronic treatment with systemic steroids or another immunosuppressive agent
- Patients should not receive immunization with attenuated live vaccines during study period or within one week of study entry
- Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
- Other malignancies within the past 3 years except for adequately treated or basal squamous cell carcinomas of the skin
- Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- Known history of HIV seropositivity
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumarin)
- Men able to conceive and unwilling to practice an effective method of birth control
- Known hypersensitivity to RAD001 or other rapamycins or to its excipients
- History of noncompliance to medical regimens
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00630344
Start Date
February 1 2008
End Date
May 1 2012
Last Update
December 8 2017
Active Locations (2)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115