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Poor accrual and funding ended
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| Name | Class |
|---|---|
| Alliance for Clinical Trials in Oncology | OTHER |
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The purpose of this study is to learn whether it is better to receive the drug Metformin with standard of care for lung cancer or just standard of care.
Participants will need to be scheduled to undergo a surgical resection of their lung cancer at the Mayo Clinic in Rochester, Minnesota. They will be asked to provide a blood sample prior to their surgery. Samples of tumor tissue and normal lung tissue will be taken from the samples removed during your lung surgery. The tissue will be used to evaluate DNA. A skin biopsy at the edge of the incision that has already been made will be done during your surgery. We will take the skin and grow skin fibroblasts. Then we will reprogram the skin fibroblasts into induced pluripotent cells. You will be "randomized" into one of the study groups to either take Metformin for 6 months with your standard of care follow up or to receive standard of care follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | Metformin 850mg twice a day |
|
| Observation | Placebo Comparator | Standard of Care Observation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug |
|
| |
| Placebo Comparator |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction | To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected. | 2 years |
| Number of Participants With 2-year Recurrence Free Survival | To compare the 2-year recurrence free survival (RFS) rate between metformin and observation. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS) | To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Wigle, MD, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin | Metformin 850mg twice per day Metformin |
| FG001 | Observation | Standard of Care Observation Placebo Comparator: Standard of Care Observation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin | Metformin 850mg twice per day Metformin |
| BG001 | Observation | Standard of Care Observation Placebo Comparator: Standard of Care Observation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate Feasibility of Patient Randomization, Accrual, and Tissue Collection for Study Conduction | To evaluate the feasibility of patient randomization, accrual, and tissue collection in a pilot study of metformin versus observation following resection of stage IA-IIIA lung squamous cell cancer for patients by assessing the reasons patients decline randomization, tracking accrual numbers, and tracking collected tissue and reasons why tissue was not collected. | Study terminated due to poor accrual and funding ended | Posted | 2 years |
|
Adverse Events were collected over a 24 months time period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin | Metformin 850mg twice per day Metformin | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | General disorders | Systematic Assessment |
Study terminated due to poor accrual and funding ended
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dennis Wigle, M.D., Ph.D. | Mayo Clinic | 507-284-8462 | Wigle.Dennis@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2014 | May 28, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Other |
Standard of Care Observation |
|
| 4 years |
| Number of Participants With Adverse Events as a Measure of Safety | To compare participant adverse events between metformin and observation arms using CTCAE version 4. | 4 years |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Participants With 2-year Recurrence Free Survival | To compare the 2-year recurrence free survival (RFS) rate between metformin and observation. | Study terminated due to poor accrual and funding ended | Posted | 4 years |
|
|
| Secondary | Measure Metformin Sensitivity in Induced Pluripotent Stem Cells (iPS) | To develop the metformin sensitivity index based on iPS cell line metformin sensitivity measurements from the first 20 patients randomized to the metformin arm. We will then To apply the metformin sensitivity index on the remaining 25 patients randomized to metformin and the 45 observation patients (70 patients total) to compare the 2-year RFS rate between metformin-sensitive and metformin-not-sensitive patients. | Study terminated due to poor accrual and funding ended | Posted | 4 years |
|
|
| Secondary | Number of Participants With Adverse Events as a Measure of Safety | To compare participant adverse events between metformin and observation arms using CTCAE version 4. | Study terminated due to poor accrual and funding ended | Posted | 4 years |
|
|
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Observation | Standard of Care Observation Placebo Comparator: Standard of Care Observation | 0 | 2 | 0 | 2 | 0 | 2 |
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Dizziness | General disorders | Systematic Assessment |
|
| Back Pain | General disorders | Systematic Assessment |
|
| Abdominal Pain | General disorders | Systematic Assessment |
|
| Pleual Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stomach pain | General disorders | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | Systematic Assessment |
|
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |