Status:
TERMINATED
Metformin in Castration-Resistant Prostate Cancer
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
Metformin is a medication that is prescribed for people with diabetes to help the body respond better to its own insulin and decrease sugar production by the liver. This helps control the body's blood...
Detailed Description
* Each treatment cycle lasts 4 weeks (28 days). Participants will take metformin twice a day for all 28 days (except for the first 7 days of the first cycle when they will take it just once daily.) * ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- History of bilateral orchiectomies or ongoing treatment with a GnRH agonist for GnRH antagonist
- Disease progression according to PSA Working Group 2
- Minimum starting PSA (Prostate Specific Antigen) level of 2.0 ng/mL
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
Exclusion
- Symptomatic metastases
- Receiving any other agents for the treatment of prostate cancer except gonadotropin releasing hormone (GnRH) agonist or antagonist within the last 30 days
- Received any investigational cancer treatment agents within the last 30 days
- Prior treatment with docetaxel
- History of diabetes requiring drug therapy
- Current treatment with metformin or metformin treatment within the last year
- History of allergic reaction to metformin
- Have uncontrolled intercurrent illness including, but not limited to ongoing or unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Serum creatinine 1.5mg/dL or greater
- Hepatic impairment
- Need for ongoing treatment with cimetidine
- History of a different malignancy except for the following circumstances: Individuals with a history of other malignancies are eligible of they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: basal cell or squamous cell carcinoma of the skin
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01215032
Start Date
September 1 2010
End Date
January 1 2015
Last Update
May 15 2017
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115