Endometrial CancerEarly Phase 1NCT01205672
Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer
A Early Phase 1 study testing Metformin in people with Endometrial Cancer, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
The goal of this research study is to learn if metformin can affect endometrial cancer cells in women who do not have diabetes. Objectives: Primary Objectives: 1. To determine the molecular effects of metformin and associated physiologic changes in insulin/glucose metabolism on the mTOR (mammalian target of rapamycin)… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Sep 2010to 28 May 2017
- Phase
- Early 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have signed informed consent
- Patients must have histologically-confirmed endometrial adenocarcinoma, any grade (1, 2, or 3) or a mixed tumor with at least an endometrioid component
- Patients must be a candidate for surgical staging procedure
- Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months
- Patients must have a documented non-fasting plasma glucose level of less than or equal to 125 mg/dL. If non-fasting plasma glucose is greater than125 mg/dL, patients must have a fasting plasma glucose level less than or equal to 125 mg/dL
- Patients must have an adequated renal function of >60cc/min as documented by the Cockcroft Gualt creatinine clearance formula: (140 - age) x (weight Kg) DIVIDED BY Estimated GFR+ 72x serum Creatinine (non-IDMS x 85 (female)
- Patients must have adequate hepatic function as documented by a serum bilirubin < 2.5 mg/dL, regardless of whether patients have liver involvement secondary to tumor
Who cannot join
- Patients with a known history of diabetes mellitus type 1 or 2 or currently taking any hypoglycemic agents
- Patients who have received metformin or another mTOR inhibitor in the last 2 years
- Patients with uterine sarcomas
- Patients who have received prior treatment for endometrial carcinoma with cytotoxic or biologic chemotherapy. Patients who have only received hormonal therapy for endometrial cancer may be included
- Patients who have undergone definitive surgery including hysterectomy or endometrial ablation
- Patients who are not surgical candidates
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- Patients with a known hypersensitivity to metformin
- Patients with metabolic acidosis, acute or chronic, including ketoacidosis or increased risk of lactic acidosis
- Patients who have a history of excessive alcohol use
- Patients with a history of congestive heart failure requiring pharmacologic treatment
- Patients with a known history of HIV
- Patients older than 80 year of age
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this research study is to learn if metformin can affect endometrial cancer cells in women who do not have diabetes.
Objectives:
Read more
Primary Objectives:
- To determine the molecular effects of metformin and associated physiologic changes in insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in the endometrium of women with endometrial cancer
Secondary Objectives:
- To describe the effects of metformin on the histology and proliferation of the endometrium in women with endometrial cancer.
- To assess the effect of body mass index on the response to treatment with metformin
- To assess the effect of insulin resistance on the response to treatment with metformin
- To determine effects of metformin on the serum, urine and DNA biomarkers of women with endometrial cancer.
Read the detailed description
The Study Drug:
Metformin is designed to treat both diabetes and insulin resistance. Both diabetes and insulin resistance have been linked to endometrial cancer. Although you do not have a diagnosis of diabetes, metformin may still have an affect on your cancer cells.
Study Visit (before taking Metformin):
If you are found eligible to take part in this study, you will have a study visit before you begin taking Metformin. The following tests and procedures will be performed:
- Blood (about 2 tablespoons) and urine will be collected for research to look at different hormone levels.
- If needed, a fasting glucose level will be obtained.
- If you are found not to be eligible your blood, urine, and tissue for research will be discarded.
Study Drug Administration:
You will take metformin, by mouth, 1 time each morning, with breakfast, for at least 7 days and up to 30 days until your scheduled surgery is performed. You will record the dates and times you take metformin on a study drug calendar provided by the study staff. You will not take metformin on the day of your surgery.
Study Tests (on the day of your surgery):
You will bring your study drug calendar to the clinic on the day of your surgery. The following tests and procedures will also be performed:
- Blood (about 2 tablespoons) and urine will be collected for routine tests and to check different hormone levels.
- During surgery, you will have a second endometrial biopsy for biomarker testing.
Length of Study:
You will be off study after your surgical procedure.
This is an investigational study.
Up to 30 women will take part in this study. Up to 25 participants will take part at MD Anderson.
- Conditions
- Endometrial Cancer
- Being tested
- Metformin
- Keywords
- Endometrium, Gynecologic malignancy, Endometrial adenocarcinoma, Insulin/glucose metabolism, Metformin
- Medical subject headings
- Endometrial Neoplasms, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Metformin 850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery. Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Increase in s6K Expression
Baseline expression of s6K measured using Western blots, which yield ordinal results (e.g. "weak", "moderate", "strong", etc.). After treatment with metformin, expression again observed, and the percent of patients who have an increase in expression will be calculated.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study start16 Sep 2010
- Primary completion28 May 2017
- Study completion28 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Pamela Soliman, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205672
- Sponsor's protocol ID
- 2009-0927
- Other IDs
- NCI-2012-01796, CBC 965712
- Status last verified
- May 2017
- First submitted
- 17 Sep 2010
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Molecular Effects of Metformin on the Endometrium in Patients With Endometrial Cancer
- ClinicalTrials.gov ID
- NCT01205672
- Acronym / sponsor ID
- 2009-0927
- Conditions
- Endometrial Cancer
- Keywords
- Endometrium, Gynecologic malignancy, Endometrial adenocarcinoma, Insulin/glucose metabolism, Metformin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- American Cancer Society, Inc.
- Study start
- 16 Sep 2010 (actual)
- Primary completion
- 28 May 2017 (actual)
- Study completion
- 28 May 2017 (actual)
- First posted
- 20 Sep 2010 (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 research study is to learn if metformin can affect endometrial cancer cells in women who do not have diabetes.
Objectives:
Primary Objectives:
- To determine the molecular effects of metformin and associated physiologic changes in insulin/glucose metabolism on the mTOR (mammalian target of rapamycin) signaling pathway in the endometrium of women with endometrial cancer
Secondary Objectives:
- To describe the effects of metformin on the histology and proliferation of the endometrium in women with endometrial cancer.
- To assess the effect of body mass index on the response to treatment with metformin
- To assess the effect of insulin resistance on the response to treatment with metformin
- To determine effects of metformin on the serum, urine and DNA biomarkers of women with endometrial cancer.
Detailed description
The Study Drug:
Metformin is designed to treat both diabetes and insulin resistance. Both diabetes and insulin resistance have been linked to endometrial cancer. Although you do not have a diagnosis of diabetes, metformin may still have an affect on your cancer cells.
Study Visit (before taking Metformin):
If you are found eligible to take part in this study, you will have a study visit before you begin taking Metformin. The following tests and procedures will be performed:
- Blood (about 2 tablespoons) and urine will be collected for research to look at different hormone levels.
- If needed, a fasting glucose level will be obtained.
- If you are found not to be eligible your blood, urine, and tissue for research will be discarded.
Study Drug Administration:
You will take metformin, by mouth, 1 time each morning, with breakfast, for at least 7 days and up to 30 days until your scheduled surgery is performed. You will record the dates and times you take metformin on a study drug calendar provided by the study staff. You will not take metformin on the day of your surgery.
Study Tests (on the day of your surgery):
You will bring your study drug calendar to the clinic on the day of your surgery. The following tests and procedures will also be performed:
- Blood (about 2 tablespoons) and urine will be collected for routine tests and to check different hormone levels.
- During surgery, you will have a second endometrial biopsy for biomarker testing.
Length of Study:
You will be off study after your surgical procedure.
This is an investigational study.
Up to 30 women will take part in this study. Up to 25 participants will take part at MD Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminMetformin 850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have signed informed consent
- Patients must have histologically-confirmed endometrial adenocarcinoma, any grade (1, 2, or 3) or a mixed tumor with at least an endometrioid component
- Patients must be a candidate for surgical staging procedure
- Patients must either be not of child bearing potential or have a negative pregnancy test within 7 days of treatment. Patients are considered not of child bearing potential if they are surgically sterile or they are postmenopausal for greater than 12 months
- Patients must have a documented non-fasting plasma glucose level of less than or equal to 125 mg/dL. If non-fasting plasma glucose is greater than125 mg/dL, patients must have a fasting plasma glucose level less than or equal to 125 mg/dL
Key exclusion criteria (12 listed)
- Patients with a known history of diabetes mellitus type 1 or 2 or currently taking any hypoglycemic agents
- Patients who have received metformin or another mTOR inhibitor in the last 2 years
- Patients with uterine sarcomas
- Patients who have received prior treatment for endometrial carcinoma with cytotoxic or biologic chemotherapy. Patients who have only received hormonal therapy for endometrial cancer may be included
- Patients who have undergone definitive surgery including hysterectomy or endometrial ablation
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 |
|---|---|---|
| Metformin850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery. | Drug | Metformin |
Primary outcome
Number of Patients with Increase in s6K Expression
Time frame: 30 days
Baseline expression of s6K measured using Western blots, which yield ordinal results (e.g. "weak", "moderate", "strong", etc.). After treatment with metformin, expression again observed, and the percent of patients who have an increase in expression will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- UT 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.
Pamela Soliman, MD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Metformin in people with Endometrial Cancer, run by M.D. Anderson Cancer Center 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 7 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: finished, as of the sponsor's last update on 2 Jun 2017. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Patients with Increase in s6K Expression (time frame: 30 days). 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 2 Jun 2017.