- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01442870
Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
May 5, 2017 updated by: Tufts Medical Center
Prospective Evaluation of Clinical Safety of Combining Metformin With Anticancer Chemotherapy
Metformin is a drug that is normally used to treat people with diabetes.
New research has discovered that metformin may also kill cancer stem cells.
These cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer.
Future studies are envisioned to that test the efficacy of administering metformin with chemotherapy.
The purpose of this study is to assess the safety of administering metformin in combination with chemotherapy.
Since chemotherapy and cancer itself both cause adverse events by themselves, this study is designed to have a run-in stage as well as a subsequent randomization to metformin or no metformin.
The primary endpoint will compare the rate of dose-limiting toxicities between these two arms.
After a period of 3 weeks for the primary endpoint comparison, all patients will receive metformin.
Study Overview
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 79 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically documented cancer; diagnosis of hepatocellular carcinoma may be made by characteristic radiographic and/or AFP findings 33;
- Intended treatment with, or currently being treated by anti-cancer chemotherapy in the adjuvant or advanced setting;
- Age 18 to 79;
- Adequate renal function (serum creatinine levels <1.5 mg/dL [males], <1.4 mg/dL [females]). If a subject does not meet these criteria, but does have an estimated creatinine clearance >= 60 ml/min using the Cockroft-Gault calculation, they will be allowed. The Cockroft-Gault formula is CrCl = (140-age) x weight(kg)÷(Cr x72), where CrCl = estimated creatinine clearance and Cr is plasma creatinine in mg/dL;
- Adequate hepatic parameters, including aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 x upper limit of normal (ULN), total bilirubin ≤ 1.5 x ULN, and alkaline phosphatase levels ≤ 2.5 x ULN;
- Must anticipate receiving at least 3 cycles (or treatment periods of at least 3-weeks) of chemotherapy;
- Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:
- Current use of metformin (within 1 week of start of chemotherapy regimen to be assessed);
- Patients with type 2 diabetes are allowed, however they will be excluded if there is intent to use metformin for treatment of diabetes during the course of the study;
- Undergoing chemotherapy treatment concurrent with radiation therapy;
- Undergoing chemotherapy in a neoadjuvant setting prior to potentially curative surgery;
- Renal disease or renal dysfunction not meeting inclusion criteria;
- Significant medical conditions such as cardiovascular collapse (shock), acute myocardial infarction, septicemia, acute or chronic metabolic acidosis;
- History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), conditions associated with hypoxemia and pancreatitis;
- Severe dehydration;
- Clinical or laboratory evidence of hepatic disease;
- Congestive heart failure requiring pharmacologic treatment, or unstable or acute congestive heart failure;
- Known hypersensitivity to metformin hydrochloride;
- Pregnant or lactating women (serum pregnancy test will be performed for all women of child-bearing potential);
- Psychiatric illness or social situation that would limit compliance with study requirements and/or obscure results
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Metformin
|
Metformin
|
NO_INTERVENTION: No metformin
No metformin during primary endpoint assessment period (at least 3 weeks).
Patients will subsequently be initiated on metformin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of dose limiting toxicity when metformin is added to chemotherapy
Time Frame: 1 cycle (at least 3 weeks)
|
The primary endpoint of the study will be to determine whether metformin can be safely added to a chemotherapy regimen that is previously well tolerated.
The rate of dose limiting toxicities will be compared.
|
1 cycle (at least 3 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 1 cycle (at least 3 weeks)
|
Secondary endpoints will include assessment of AEs ≥ grade 3 and Serious Adverse Events (SAEs), assessment of safety beyond the first cycle with metformin, and an exploration of metformin-chemotherapy drug interactions.
|
1 cycle (at least 3 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (ACTUAL)
February 1, 2014
Study Completion (ACTUAL)
November 1, 2014
Study Registration Dates
First Submitted
September 21, 2011
First Submitted That Met QC Criteria
September 28, 2011
First Posted (ESTIMATE)
September 29, 2011
Study Record Updates
Last Update Posted (ACTUAL)
May 9, 2017
Last Update Submitted That Met QC Criteria
May 5, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Metformin Anticancer + Chemo
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Johns Hopkins UniversityNational Cancer Institute (NCI); National Institute on Minority Health and...Enrolling by invitationCancer | Advanced Cancer | End Stage Cancer | MalignancyUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
Clinical Trials on Metformin
-
Anji PharmaSuspendedDiabetes Mellitus, Type 2Spain, United States, Canada, Hungary, Brazil, Czechia, Poland, Bulgaria
-
ShionogiCompleted
-
NuSirt BiopharmaCompletedType 2 Diabetes MellitusUnited States
-
Bristol-Myers SquibbCompletedType 2 Diabetes MellitusSouth Africa, United States, Canada, Puerto Rico, Hungary, Germany, Czechia, Poland, Romania, United Kingdom
-
Charles University, Czech RepublicCompleted
-
Hoffmann-La RocheCompletedDiabetes Mellitus Type 2United States, Mexico, Argentina
-
Hadassah Medical OrganizationWithdrawn
-
Woman'sPfizer; American Cancer Society, Inc.; Our Lady of the Lake Regional Medical...WithdrawnInsulin Resistance | Breast Cancer Stage | Racial BiasUnited States
-
Garvan Institute of Medical ResearchWeizmann Institute of ScienceActive, not recruitingType 2 Diabetes Mellitus | Pre DiabetesAustralia
-
University Hospital, Basel, SwitzerlandCompletedBecker's Muscular Dystrophy (BMD)Switzerland