Status:
COMPLETED
Bicalutamide With or Without Everolimus in Treating Patients With Recurrent or Metastatic Prostate Cancer
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
Novartis
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Everolimus may stop the growth of tu...
Detailed Description
OBJECTIVES: * To compare the PSA response rate in patients with hormone-independent recurrent or metastatic adenocarcinoma of the prostate treated with bicalutamide and everolimus after first-line an...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participants must be adult males \>18 years.
- Patients must have histologically or cytologically confirmed CaP with a Gleason score available or interpretable.
- Patients must have CaP deemed to be androgen independent.
- Measurable disease is not required.
- Patients must have been surgically or medically castrated. If the method of castration was LHRH agonists (leuprolide or goserelin) or antagonists (degarelix), then the patient must be willing to continue the use of LHRH agonists or antagonists. Serum testosterone must be at castrate levels (\< 50 ng/dL) within 3 months prior to registration.
- Participant has not been on any previous therapy with androgen receptor antagonists or mTOR inhibitors. Note: patients who have taken an androgen receptor antagonist for a brief period (no more than 2 months) at the start of LHRH agonist therapy to prevent flare will be considered eligible.
- Men enrolled in this trial must agree to use adequate contraception prior to study entry and for the duration of study participation.
- Patients must have normal organ and marrow function.
- Ability to understand and the willingness to sign a written informed consent document
- ECOG performance status 0-2.
- Patients having any respiratory symptoms such as cough and shortness of breath have undergone pulmonary function testing revealing no worse than mild impairment.
- Exclusion Criteria
- No documented histological confirmation of CaP.
- Patient has received other hormonal therapy besides first-line androgen deprivation therapy with LHRH agonist, LHRH antagonist, orchiectomy, high-dose steroid, abiraterone, provenge and ketoconazole.
- Patients who have received prior treatment with an mTOR inhibitor.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with RAD001.
- Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation therapy, antibody based therapy, etc.)
- Patients who have had a major surgery or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or patients that may require major surgery during the course of the study.
- Prior treatment with any investigational drug within the preceding 4 weeks.
- Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
- Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.
- Patients on herbs or other alternative medicines for the treatment of prostate cancer, including but not limited to saw palmetto, PC-SPES.
- 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 basal or squamous cell carcinomas of the skin or other Stage 0 or I cancers.
- Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001.
- Patients with an active, bleeding diathesis.
- History of noncompliance to medical regimens.
- Patients unwilling to or unable to comply with the protocol.
- Patients with active pulmonary disorders or history of moderately to severely impaired pulmonary function tests will be excluded from the study.
- Patients with symptomatic metastatic prostate cancer such as moderate to severe pain, impaired organ function or spinal cord compression will be excluded from this study unless these issues have been taken care of.
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00814788
Start Date
December 1 2008
End Date
January 1 2016
Last Update
January 10 2018
Active Locations (1)
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1
University of California Davis Cancer Center
Sacramento, California, United States, 95817