A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women
Overview[ - collapse ][ - ]
| Purpose | The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients. |
|---|---|
| Condition | Adenocarcinoma of the Endometrium |
| Intervention | Drug: Metformin |
| Phase | Phase 2 |
| Sponsor | University of Arkansas |
| Responsible Party | University of Arkansas |
| ClinicalTrials.gov Identifier | NCT01877564 |
| First Received | June 11, 2013 |
| Last Updated | November 12, 2013 |
| Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 11, 2013 |
|---|---|
| Last Updated Date | November 12, 2013 |
| Start Date | June 2013 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | IHC-based tissue markers of proliferation: ki67, phosphorylated histone H3, estrogen receptor (ER), progesterone receptor (PR), and telomerase (hTERT) [Time Frame: 1 year] [Designated as safety issue: Yes] |
| Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
| Brief Title | A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women |
|---|---|
| Official Title | A Randomized Pilot Study to Evaluate the Effects of a Short Course of Metformin Versus No Therapy in the Period Prior to Hysterectomy for Grade 1-2 Adenocarcinoma of the Endometrium in Obese Non-Diabetic Women |
| Brief Summary | The purpose of this research is to determine the effects of Metformin, a well tolerated drug widely prescribed for treatment of Type 2 Diabetes Mellitus, on endometrium cancer patients. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Intervention Model: Parallel Assignment, Primary Purpose: Treatment |
| Condition | Adenocarcinoma of the Endometrium |
| Intervention | Drug: Metformin |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 40 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | June 2015 |
| Eligibility Criteria | Inclusion Criteria: - Histological confirmed diagnosis of grade I or II adenocarcinoma of the endometrium - Must be obese as defined by a body mass index (BMI) greater than or equal to 30 kg/m2 - Candidate for surgical removal of their uterus as part of their endometrial cancer treatment - Subjects must have signed informed consent - Age 42 - 65 years of age - Electrocorticogram (ECOG) Performance status of 0 - 2 - History of adequate renal, liver, and bone marrow function: - Hb: (adequate for surgical intervention, with transfusion if necessary) White Blood Cell (WBC): (normal range) - Platelets: (180K/cmm) - Liver Function Test(LFTs): Normal bilirubin (<2.0mg/dL), AST/ALT (2xULN) - Renal function: creatinine less than 1.4 - Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of randomization to Metformin. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months. Exclusion Criteria: - Poorly differentiated cancer or any of the high-risk subtypes of endometrial cancer including serous, clear cell, or carcinosarcoma - History of diabetes mellitus Type 1 or Type 2. - Receiving metformin prior to enrollment - Known hypersensitivity to metformin. - Unable to swallow and retain oral medication. - Pregnant or lactating. - Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years - If the physician feels that the candidate is not suitable for the study, he/she will be excluded. - Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR or DPP-4 inhibitors or having taken any of these medications during the 12 weeks prior to study participation. - Currently taking any non-steroidal anti-inflammatory drugs (NSAIDs) or aspirin and unable to stop such medications due to a present medical condition. - Clinical symptoms of gastrointestinal obstruction or bleeding and consideration for immediate surgery or immediate neoadjuvant chemoradiation. - History of lactic or other metabolic acidosis. - Uncontrolled infectious disease. - History of positivity for human immunodeficiency virus (HIV). - History of congestive heart failure requiring pharmacologic treatment. - History of excessive alcohol abuse, defined by a habitual intake of more than three drinks daily. - Mal-absorption syndrome, disease affecting gastrointestinal function, or previous resection of the stomach or small bowel. - Current use of medications for weight loss. - Currently taking cimetidine, thiazide diuretics or cephalexin. If a patient needs some of these agents, alternative agents should be substituted. |
| Gender | Female |
| Ages | 45 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Alexander Burnett, MD 501-296-1099 ABurnett@uams.edu |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01877564 |
|---|---|
| Other Study ID Numbers | 138647 |
| Has Data Monitoring Committee | No |
| Information Provided By | University of Arkansas |
| Study Sponsor | University of Arkansas |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | November 2013 |
Locations[ + expand ][ + ]
| University of Arkansas for Medical Sciences | Little Rock, Arkansas, United States, 72205 Contact: Alexander Burnett, MD | 501-296-1099 | ABurnett@uams.eduPrincipal Investigator: Alexander Burnett, MD Recruiting |
|---|