Metformin Hydrochloride as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer
RATIONALE: Metformin hydrochloride may make some enzymes active. These enzymes may block other enzymes needed for cell growth and stop the growth of tumor cells.
PURPOSE: This phase II trial is studying the safety of giving metformin hydrochloride as first-line therapy in treating patients with locally advanced or metastatic prostate cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metformin in Castration Resistant Prostate Cancer. A Multicenter Phase II Trial.|
- Progression-free survival (PFS) [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
- PFS [ Time Frame: at 24 weeks ] [ Designated as safety issue: No ]
- Clinical benefit rate [ Time Frame: at 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: n.a. ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: n.a. ] [ Designated as safety issue: Yes ]
- Prostate-specific antigen (PSA) response [ Time Frame: (50% and 30%, best and at 12 weeks) ] [ Designated as safety issue: No ]
- Changes in PSA doubling time [ Time Frame: n.a. ] [ Designated as safety issue: No ]
- Tumor response of measurable disease according to RECIST v 1.1 criteria [ Time Frame: n.a. ] [ Designated as safety issue: No ]
- Tumor assessment of bone lesions [ Time Frame: n.a. ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: n.a. ] [ Designated as safety issue: No ]
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Drug: metformin hydrochloride
Metformin Lifelong follow-up at a target dose of 2 x 1000 mg daily Until progression, unacceptable toxicity or refusal
Other Name: Metformin-Mepha
- To determine the activity and safety of metformin hydrochloride as first-line therapy in patients with locally advanced or metastatic castration-resistant prostate cancer.
OUTLINE: This is a multicenter study.
Patients receive oral metformin hydrochloride twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Previously collected and post-treatment tumor tissue may be analyzed for PTEN status and PI3kinase-dependent pathway activation via immunohistochemistry. Blood samples may also be collected periodically and analyzed for biomarkers, pharmacogenetics, pharmacodynamics, pharmacokinetics.
After completion of study therapy, patients are followed up every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243385
|Aarau, Switzerland, CH-5001|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Chur, Switzerland, CH-7000|
|Luzerne, Switzerland, CH-6000|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Winterthur, Switzerland, CH-8401|
|Zurich, Switzerland, 8038|
|Zurich, Switzerland, CH-8091|
|Study Chair:||Christian Rothermundt, MD||Cantonal Hospital of St. Gallen|
|Study Chair:||Richard Cathomas, MD||Kantonsspital Graubuenden|
|Study Chair:||Silke Gillessen, MD||Cantonal Hospital of St. Gallen|