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:||Intervention Model: Single Group Assignment
Masking: None (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 (PFS) at 12 weeks [ Time Frame: at 12 weeks ]PFS at 12 weeks is defined as the absence of disease progression or death at 12 weeks after start of treatment.
- PFS at 24 weeks [ Time Frame: at 24 weeks ]PFS at 24 weeks is defined as the absence of any disease progression or death at 24 weeks after start of treatment.
- Progression-free survival [ Time Frame: from start of treatment until progression or death of any cause ]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 (AEs) according to NCI CTCAE v. 3.0 [ Time Frame: from start of treatment until progression or death of any cause ]All AEs will be assessed according to NCI CTCAE v3.0
- PSA response [ Time Frame: 50% and 30%, best and at 12 weeks ]
50% PSA response is defined as a decrease in PSA level of at least 50% (compared to baseline PSA).
30% PSA response is defined as a decrease in PSA level of at least 30% (compared to baseline PSA).
Best response is defined as the percentage of change in PSA from baseline to the maximum decline in PSA at any point under treatment.
Response at 12 weeks is defined as the percentage of change in PSA from baseline to 12 weeks (or earlier for those patients who discontinue therapy, in this case last PSA values recorded should be taken).
- Changes in PSA-doubling time [ Time Frame: Time points for later calculations include: after 12 weeks, after 24 weeks and at best PSA response ]PSA-DT is calculated by natural log of 2 divided by the slope of the relationship between the log of PSA and time of PSA measurement for each patient.
- 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. ]For patients with measurable disease at baseline RECIST v1.1 will be used to define CR, PR, SD and PD.
- Tumor assessment of bone lesions [ Time Frame: at 12 weeks. ]Bone metastases can be assessed by radionuclide bone scan.
|Actual Study Start Date:||September 14, 2009|
|Estimated Study Completion Date:||December 31, 2017|
|Primary Completion Date:||November 29, 2012 (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976755
|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|