Colorectal NeoplasmsPhase 2NCT01632020
Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
A Phase 2 study testing Metformin in people with Colorectal Neoplasms, run by University of Arkansas at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma. It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Jan 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, all races and ethnicities are eligible
- Age equal to or greater than 18 years of age
- All subjects should have a pathological/histological diagnosis of colorectal cancer.
- Clinical diagnosis of stage I, II, III or IV colon cancer or stage I, II, III or IV rectal cancer; cancer may be primary including a secondary primary
- Candidate for elective surgery(for removal of primary) or endoscopic biopsy
- ECOG Performance status of 0 - 2
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- Adequate renal, liver, and bone marrow function
- Hb: (adequate for surgical intervention, with transfusion if necessary)
- WBC: (normal range)
- Platelets: (180K/cmm)
- LFTs: Normal bilirubin (< 2.0mg/dL), AST/ALT (2xULN)
- Renal function: normal creatinine
- Subjects must have signed informed consent
- Female subjects must either not be of child-bearing potential or must have a negative urine pregnancy test within 7 days of beginning the drug or placebo treatment. Subjects are considered not of child-bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months.
Who cannot join
- Previously diagnosed with diabetes mellitus Type 1 or Type 2.
- Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR 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.
- Familial Adenomatous Polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
- Pregnant or lactating.
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- History of lactic or other metabolic acidosis.
- Known hypersensitivity to Metformin.
- 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.
- Previous or concurrent malignancies, except non-melanoma skin cancers, unless curatively treated and with no evidence of recurrence for > 5 years, with the exception of prior CRC which has been treated and the patient has been in remission and the current primary tumor is a second CRC.
- Unable to swallow and retain oral medication.
- 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.
- If the physician feels that the candidate is not suitable for the study, he/she will be excluded.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Central Arkansas Veterans Heathcare System
Little Rock, Arkansas, 72205
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Pilot Study: Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma.
It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
Read the detailed description
This is a randomized, double-blinded placebo controlled clinical investigation of the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma. Metformin is a well-tolerated drug widely prescribed for treatment of Type 2 diabetes mellitus. Preliminary studies have generated the hypothesis that metformin may have positive effects on both prevention and survival of colon cancer subjects. Clinical trials are ongoing to explore this possibility in breast cancer (NCT01101438). This investigation is the first study of Metformin in colorectal cancer (CRC) patients, and is designed to understand the mechanism of its anti-cancer actions, if any, and its interactions with biomarkers in colorectal cancer patients.
Based upon epidemiological studies, it is hypothesized that there are independent actions of Metformin on the outcome of subjects with CRC. Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
- Conditions
- Colorectal Neoplasms
- Being tested
- Placebo, Metformin
- Keywords
- colorectal tumor, colorectal cancer, colorectal carcinoma, neoplasms, colorectal, Metformin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called inactive drug
2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
MetforminDrug
Also called Glucophage, Glucophage XR, Glumetza, Fortamet
850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days Receives: Drug: Placebo |
| Metformin | Active comparator | Metformin 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Measured: 10-21 days
Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Measured: 10-21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Inadequate accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rangaswamy Govindarajan, MD, Principal investigator, University of ArkansasFrank Simmen, PhD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632020
- Sponsor's protocol ID
- 134190
- Status last verified
- May 2016
- First submitted
- 27 Jun 2012
- Last updated
- 11 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
- ClinicalTrials.gov ID
- NCT01632020
- Acronym / sponsor ID
- 134190
- Conditions
- Colorectal Neoplasms
- Keywords
- colorectal tumor, colorectal cancer, colorectal carcinoma, neoplasms, colorectal, Metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Posted 11 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma.
It is hypothesized that there are independent actions of Metformin on the outcome of subjects with colorectal cancer (CRC). Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
Detailed description
This is a randomized, double-blinded placebo controlled clinical investigation of the effects of short term oral Metformin therapy on biomarkers for tumor growth in subjects with newly diagnosed colon or rectal adenocarcinoma. Metformin is a well-tolerated drug widely prescribed for treatment of Type 2 diabetes mellitus. Preliminary studies have generated the hypothesis that metformin may have positive effects on both prevention and survival of colon cancer subjects. Clinical trials are ongoing to explore this possibility in breast cancer (NCT01101438). This investigation is the first study of Metformin in colorectal cancer (CRC) patients, and is designed to understand the mechanism of its anti-cancer actions, if any, and its interactions with biomarkers in colorectal cancer patients.
Based upon epidemiological studies, it is hypothesized that there are independent actions of Metformin on the outcome of subjects with CRC. Also hypothesized is that metformin effects on CRC cell growth will correlate with this drug's effects on markers mentioned above, because the markers are closely related to tumor growth and metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days |
| Metformin | Active comparator | Drug: MetforminMetformin 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Male or female, all races and ethnicities are eligible
- Age equal to or greater than 18 years of age
- All subjects should have a pathological/histological diagnosis of colorectal cancer.
- Clinical diagnosis of stage I, II, III or IV colon cancer or stage I, II, III or IV rectal cancer; cancer may be primary including a secondary primary
- Candidate for elective surgery(for removal of primary) or endoscopic biopsy
Key exclusion criteria (18 listed)
- Previously diagnosed with diabetes mellitus Type 1 or Type 2.
- Currently taking biguanides, sulfonylurea drugs, thiazolidinediones, insulin, or mTOR 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.
- Familial Adenomatous Polyposis (FAP), hereditary non-polyposis colorectal cancer (HNPCC), Putz-Jeghers disease, ulcerative colitis, or Crohn's disease.
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 |
|---|---|---|
| PlaceboAlso: inactive drug2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days | Drug | Placebo |
| MetforminAlso: Glucophage, Glucophage XR, Glumetza, Fortamet850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days | Drug | Metformin |
Primary outcome
Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Time frame: 10-21 days
Mucosal Apoptotic Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy
Time frame: 10-21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Rangaswamy Govindarajan, MD principal investigator
University of Arkansas
Frank Simmen, PhD principal investigator
University of Arkansas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Colorectal Neoplasms, run by University of Arkansas at 2 sites 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 14 inclusion and 18 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 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proliferation Status of CRC Tumor and Adjacent Normal Tissue Following Metformin Therapy (time frame: 10-21 days). The study lists 2 primary outcomes in all. 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 11 Jul 2016.