Phase II Trial of Bicalutamide and RAD001 in Patients With Hormone-Independent Prostatic Adenocarcinoma (HIPC) After the First-Line Androgen Deprivation Therapy
Overview
- Phase
- Phase 2
- Intervention
- Bicalutamide
- Conditions
- Prostate Cancer
- Sponsor
- University of California, Davis
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- PSA Response Rate
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying bicalutamide and everolimus to see how well they work compared with bicalutamide in treating patients with recurrent or metastatic prostate cancer.
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 androgen deprivation therapy. * To evaluate the time to treatment failure and overall survival of these patients. * To assess the toxicity of bicalutamide and everolimus in these patients. OUTLINE: Patients are stratified according to disease status (metastatic disease vs biochemical recurrence without measurable disease). Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 28-42 days and then every 3 months thereafter.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Bicalutamide + Everolimus
Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Bicalutamide
Bicalutamide + Everolimus
Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Intervention: Everolimus
Outcomes
Primary Outcomes
PSA Response Rate
Time Frame: Up to 2 years
The PSA response rate was defined as a 30% reduction in the PSA level from baseline. PSA Working Group consensus criteria combined with radiographic studies were used to determine the proportion of patients with PSA decline.
Secondary Outcomes
- Progression-free Survival(Up to 2 years)
- Overall Survival(Up to 3 years)