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

Prostate Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00976755
• Study type: Interventional
• Source: Swiss Group for Clinical Cancer Research
• Status: Completed
• Phase: Phase 2
• Start date: September 14, 2009
• Completion date: August 8, 2019