Status:
COMPLETED
Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenocarcinoma of the Prostate
Recurrent Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
This randomized phase II trial studies how well metformin hydrochloride works compared to placebo in treating patients with prostate cancer undergoing surgery. Metformin hydrochloride may make some en...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the effect of 4-12 weeks of metformin (metformin hydrochloride) intervention on cell proliferation in the prostatectomy tissue. SECONDARY OBJECTIVES: I. To deter...
Eligibility Criteria
Inclusion
- Men will be eligible to this study if they are diagnosed with a histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) treatable by prostatectomy and have a current PSA less than 50 ng/ml
- Have not received chemotherapy and/or radiation for any malignancy (excluding non-melanoma skin cancer and cancers confined to organs with removal as only treatment) in the past 5 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (Karnofsky \>= 70%)
- Leukocytes \>= 3,000/uL
- Absolute neutrophil count \>= 1,500/uL
- Platelets \>= 100,000/uL
- Total bilirubin =\< 1.5 times institutional upper limits of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 times institutional ULN
- Creatinine within normal institutional limits
- Willing to use adequate contraception (barrier method, abstinence, subject has had a vasectomy or partner is using effective birth control or is postmenopausal) for the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
Exclusion
- Type I or type II diabetic patients on treatment with any drug for diabetes or participants with fasting glucose \>= 126 mg/dL
- History of impaired liver or kidney function
- Participants with a current history of high alcohol consumption (\> 3 standard drinks/day) or binge drinking (5 or more drinks) in one session of 1-3 hours
- History of lactic acidosis or at increased risk for lactic acidosis such as patients with unstable or acute congestive heart failure who are at risk of hypoperfusion with hypoxemia
- Participants may not be receiving any other investigational agents
- History of allergic reactions attributed to compounds of similar chemical composition to metformin
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- History of acute or chronic metabolic acidosis
- Concurrent use of cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin)
- Concurrent use of non-study metformin or other biguanides
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01433913
Start Date
November 1 2011
End Date
April 1 2014
Last Update
January 10 2018
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Arizona Cancer Center - Tucson
Tucson, Arizona, United States, 85724-5024
2
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
3
University of Southern California/Norris Cancer Center
Los Angeles, California, United States, 90033