Colorectal CarcinomaPhase 1NCT01816659
An Open-Labeled Pilot Study of Biomarker Response Following Short-Term Exposure to Metformin
A Phase 1 study testing Metformin ER in people with Colorectal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Metformin ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18- 75 years
- Colonic lesion that should be removed surgically:
- 2.a. CRC that is potentially resectable and not requiring neoadjuvant treatment.
- 2.b. Endoscopically non-resectable adenoma.
- 2.c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy.
- Need for perioperative colonoscopy as a part of standard of care evaluation:
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- 6.a. CRC or adenoma for which the colorectal surgeon requires a preoperative colonoscopy or sigmoidoscopy for any reason, including but not limited to:
- 6.a.a. No outside colonoscopy
- 6.a.b. No outside pathology
- 6.a.c. Partially obstructing tumor or
- 6.a.d. Otherwise unsatisfactory outside colonoscopy
- 6.a.e. Rectal cancer requiring EUS
- 6.a.f. Second opinion on adenoma regarded as endoscopically non-resectable on outside colonoscopy; or
- 6.b. Patient found on initial MDACC colonoscopy to have CRC or endoscopically non-resectable adenoma, most commonly patients undergoing average or high risk (familial, history of adenoma) screening colonoscopy.
- Ability to give informed consent.
- Diabetic patients are eligible but they may be excluded if they are taking Metformin, insulin or sulfonylureas.
Who cannot join
- Patients with renal insufficiency defined as serum creatinine >= 1.4 mg/dl for females and >= 1.5 mg/dl for males
- Pregnant or nursing women
- A malignancy currently under active therapy
- Unstable angina
- Uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification)
- Current usage of Metformin
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- Current usage of insulin, sulfonylureas
- History of lactic acidosis
- Chronic liver disease or cirrhosis
- Inability to give informed consent
- Other investigational drugs within the past one year or concurrently
- Known hypersensitivity or intolerance to Metformin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Open-Labeled Pilot Study of Biomarker Response in Patients With Colorectal Cancer or Endoscopically Non-Resectable Adenomas Following Short-Term Exposure to Metformin Extended Release (ER)
The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied.
Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.
Read the detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
- If you are in Group 1, you will receive metformin ER. You will have a 2 in 3 chance of being assigned to Group 1.
- If you are in Group 2, you will receive no treatment. You will have a 1 in 3 chance of being assigned to Group 2.
Study Drug Administration:
If you are in Group 1, You will start taking the drug the day after your colonoscopy (or later if your surgery is scheduled to be more than 30 days after the colonoscopy) and will continue to take it until your scheduled surgery (for up to 30 days). During the first week you will take one tablet of metformin-ER by mouth one time each day with food. From the beginning of the second week until your scheduled surgery, you will take two tablets of metformin-ER by mouth one time each day with food. If you have side effects, your dose may be lowered.
If you are in Group 2, you will not receive any study drug from the time of your colonoscopy until surgery.
Study Visits:
On the day of your colonoscopy:
- Your medical history will be recorded and you will be asked about any drugs you may be taking.
- You will have a physical exam.
- Extra tissue samples will be collected during the colonoscopy for routine and biomarker testing. Biomarkers are small pieces of material or substances found in you tissue that may provide information about your condition or the disease.
- The study staff will call you 1 week after your colonoscopy and ask about your general health and about any side effects you may be having.
On the day before surgery or the day of the surgery itself:
- Your weight will be measured.
- Blood (about 3 tablespoons) will be drawn for routine tests and for research about the safety of metformin-ER and how it may affect the disease. This routine blood draw will include a pregnancy test if you are able to become pregnant.
- You will be asked about your general health and about any side effects you may be having.
- During the surgery, extra tissue samples will be collected for biomarker testing.
Length of Study:
You will be on study for up to 30 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have had the surgery.
This is an investigational study. Metformin-ER is FDA approved and commercially available for the treatment of type 2 diabetes. Its use in this study is investigational.
Up to 23 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Colorectal Carcinoma
- Being tested
- Metformin ER
- Keywords
- Colorectal Carcinoma, Endoscopically Non- Resectable Adenomas, Colonic lesion, Biomarker, Metformin-ER, Metformin, Extended release, Colonoscopy, Colon cancer surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin ERDrug
Also called Metformin
500 mg by mouth once daily, beginning the day after colonoscopy for one week, and then escalation to 1000 mg/day. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.
| Study group | Role | What they receive |
|---|---|---|
| Metformin + Colon Surgery | Experimental | Patients randomized to Metformin-ER 500 mg once daily for one week and then escalation to 1000 mg/day for the duration of the trial. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days. Receives: Drug: Metformin ER |
| Colon Surgery Alone | No intervention | Patients will not receive any study drug from the time of colonoscopy until surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Ki-67 in Tumor Samples
Primary outcome measure is change in the percentage of Ki67-positive-staining cells between the baseline colonoscopy and surgery in the colon rectal cancer/non-resectable adenoma samples.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Lynch, MD, JD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816659
- Sponsor's protocol ID
- 2012-1150
- Other IDs
- NCI-2013-00994
- Status last verified
- Aug 2014
- First submitted
- 20 Mar 2013
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled Pilot Study of Biomarker Response in Patients With Colorectal Cancer or Endoscopically Non-Resectable Adenomas Following Short-Term Exposure to Metformin Extended Release (ER)
- ClinicalTrials.gov ID
- NCT01816659
- Acronym / sponsor ID
- 2012-1150
- Conditions
- Colorectal Carcinoma
- Keywords
- Colorectal Carcinoma, Endoscopically Non- Resectable Adenomas, Colonic lesion, Biomarker, Metformin-ER, Metformin, Extended release, Colonoscopy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 3 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical research study is to learn more about the possible effects of metformin extended release (ER) in patients with colon cancer or adenomas who are about to have surgery. The safety of this drug will also be studied.
Metformin-ER is commonly used to control blood sugar levels in patients with diabetes. It is also designed to block a protein in tumor cells that is important in tumor growth and blood vessel development. This may cause cell death or reduce the spread of the disease.
Detailed description
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
- If you are in Group 1, you will receive metformin ER. You will have a 2 in 3 chance of being assigned to Group 1.
- If you are in Group 2, you will receive no treatment. You will have a 1 in 3 chance of being assigned to Group 2.
Study Drug Administration:
If you are in Group 1, You will start taking the drug the day after your colonoscopy (or later if your surgery is scheduled to be more than 30 days after the colonoscopy) and will continue to take it until your scheduled surgery (for up to 30 days). During the first week you will take one tablet of metformin-ER by mouth one time each day with food. From the beginning of the second week until your scheduled surgery, you will take two tablets of metformin-ER by mouth one time each day with food. If you have side effects, your dose may be lowered.
If you are in Group 2, you will not receive any study drug from the time of your colonoscopy until surgery.
Study Visits:
On the day of your colonoscopy:
- Your medical history will be recorded and you will be asked about any drugs you may be taking.
- You will have a physical exam.
- Extra tissue samples will be collected during the colonoscopy for routine and biomarker testing. Biomarkers are small pieces of material or substances found in you tissue that may provide information about your condition or the disease.
- The study staff will call you 1 week after your colonoscopy and ask about your general health and about any side effects you may be having.
On the day before surgery or the day of the surgery itself:
- Your weight will be measured.
- Blood (about 3 tablespoons) will be drawn for routine tests and for research about the safety of metformin-ER and how it may affect the disease. This routine blood draw will include a pregnancy test if you are able to become pregnant.
- You will be asked about your general health and about any side effects you may be having.
- During the surgery, extra tissue samples will be collected for biomarker testing.
Length of Study:
You will be on study for up to 30 days. You will no longer be able to take the study drug if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation on the study will be over once you have had the surgery.
This is an investigational study. Metformin-ER is FDA approved and commercially available for the treatment of type 2 diabetes. Its use in this study is investigational.
Up to 23 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin + Colon Surgery | Experimental | Drug: Metformin ERPatients randomized to Metformin-ER 500 mg once daily for one week and then escalation to 1000 mg/day for the duration of the trial. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days. |
| Colon Surgery Alone | No intervention | –Patients will not receive any study drug from the time of colonoscopy until surgery. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age between 18- 75 years
- Colonic lesion that should be removed surgically:
- 2.a. CRC that is potentially resectable and not requiring neoadjuvant treatment.
- 2.b. Endoscopically non-resectable adenoma.
- 2.c. Familial Adenomatous Polyposis (FAP) patient that requires colectomy or proctocolectomy.
Key exclusion criteria (12 listed)
- Patients with renal insufficiency defined as serum creatinine >= 1.4 mg/dl for females and >= 1.5 mg/dl for males
- Pregnant or nursing women
- A malignancy currently under active therapy
- Unstable angina
- Uncontrolled ischemic cardiac disease or symptomatic congestive heart failure (e.g. Class III or IV New York Heart Association's Functional Classification)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin ERAlso: Metformin500 mg by mouth once daily, beginning the day after colonoscopy for one week, and then escalation to 1000 mg/day. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days. | Drug | Metformin + Colon Surgery |
Primary outcome
Comparison of Ki-67 in Tumor Samples
Time frame: 2 weeks
Primary outcome measure is change in the percentage of Ki67-positive-staining cells between the baseline colonoscopy and surgery in the colon rectal cancer/non-resectable adenoma samples.
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Lynch, MD, JD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Metformin ER in people with Colorectal Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Ki-67 in Tumor Samples (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.