Everolimus as First-Line Therapy in Treating Patients With Prostate Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Everolimus First-line Therapy in Non-rapidly Progressive Castration Resistant Prostate Cancer (CRPC). A Multicenter Phase II Trial.|
- Progression-free survival [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: from start of treatment until progression or death of any cause ] [ Designated as safety issue: No ]from start of treatment until progression or death of any cause, whereas it will be censored at the last follow-up visit or initiation of a different treatment.
- Adverse events according to NCI CTCAE v. 3.0 [ Time Frame: from start of treatment until progression or death of any cause ] [ Designated as safety issue: Yes ]
- PSA response [ Time Frame: 50% and 30%, best and at 12 weeks ] [ Designated as safety issue: No ]
- Changes in PSA-doubling time [ Time Frame: Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response ] [ Designated as safety issue: No ]
- Tumor assessment of measurable disease according to RECIST v1.1 criteria [ Time Frame: The first assessment will be performed after 12 weeks of treatment, or earlier if clinically indicated. ] [ Designated as safety issue: No ]
- Tumor assessment of bone lesions [ Time Frame: at 12 weeks. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Arm A: Everolimus
- 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.
- 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.
|Aarau, Switzerland, CH-5001|
|Baden, Switzerland, 5404|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Biel, Switzerland, CH-2501|
|Chur, Switzerland, 7000|
|Hopital Cantonal Universitaire de Geneve|
|Geneva, Switzerland, CH-1211|
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Luzern, Switzerland, 6000|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Winterthur, Switzerland, 8401|
|Zurich, Switzerland, 8091|
|Zurich, Switzerland, CH-8091|
|Principal Investigator:||Arnoud Templeton, MD||Cantonal Hospital of St. Gallen|
|Study Chair:||Silke Gillessen, MD||Cantonal Hospital of St. Gallen|