NCT00976755

Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer

Everolimus First-line Therapy in Non-rapidly Progressive Castration Resistant Prostate Cancer (CRPC). A Multicenter Phase II Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying the side effects of everolimus and to see how well it works as first-line therapy in treating patients with prostate cancer.

Detailed description

OBJECTIVES: Primary * Determine the progression-free survival at 12 weeks of patients with non-rapidly progressive castration-resistant prostate cancer treated with everolimus as first-line therapy. * Assess the activity and safety of this regimen in these patients. Secondary * Determine the progression-free survival at 24 weeks of patients treated with this regimen. * Determine the percentage of PSA response from baseline to 12 weeks in patients treated with this regimen. * Determine the changes in PSA-doubling time in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up at 28 days and then every 3 months.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	everolimus	Everolimus: 10mg daily

Timeline

• Start date: 2009-09-14
• Primary completion: 2012-11-29
• Completion: 2019-08-08
• First posted: 2009-09-14
• Last updated: 2019-08-09

Locations

13 sites across 1 country: Switzerland