Metformin With Neoadjuvant Chemoradiation to Improve Pathologic Responses in Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-08

Study Completion Date

2019-06-26

Brief Summary

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This study is a phase II, single arm, controlled, open label internal pilot.

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Detailed Description

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This internal pilot will be the first prospective study to assess the feasibility and efficacy of adding metformin in non-diabetic rectal patients who undergo standard of care neoadjuvant chemoradiation therapy (CRT). The translational aim of the study will inform on predictive factors (such as p53) and mechanism of action (hypoxia, proliferation). Metformin has been used for decades in patients with type 2 diabetes and has an extremely safe toxicity profile. With current interest in the use of metformin as a cancer therapeutic in non-diabetics, this study is expected to provide proof-of principle data for a larger study.

Conditions

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Rectal Neoplasm Carcinoma in Situ Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin

Participants will self-administer 500mg metformin twice daily by mouth: 1) beginning 1 to 2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Participants will self-administer 500mg metformin twice daily by mouth: 1) beginning 1-2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.

Interventions

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Metformin

Participants will self-administer 500mg metformin twice daily by mouth: 1) beginning 1-2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Plan for care inclusive of:

i. standard of care neoadjuvant chemoradiation ii. planned total mesorectal excision (TME)
2. Histologically confirmed adenocarcinoma of the rectum
3. At least one of the following:

i. T3 or T4 lesions ii. T2 lesions ≤ 1 mm to the mesorectal fascia iii. Node positive rectal tumor
4. ECOG performance status of 0 or 1
5. Provide written informed consent
6. Female participants of childbearing potential agree to use adequate methods of contraception from the start of metformin administration until the start of CRT. Contraception will not be required to be continued during or after CRT as this treatment renders participants infertile. Clinically acceptable methods of birth control for this study include intrauterine devices (IUD), birth control pills, hormonal implants, injectable contraceptives, and using barrier methods such as condoms, vaginal diaphragm with spermicide, or sponge.

Exclusion Criteria

1. Diagnosis of diabetes
2. Current use of metformin
3. Prior pelvic radiation
4. Life expectancy \< 6 months.
5. Active infection
6. Creatinine \> 1.5X ULN, within 1 month prior to baseline
7. AST, ALT \> 2.5X ULN, within 1 month prior to baseline
8. Bilirubin \> 1.5 ULN, within 1 month prior to baseline
9. Pregnant or breastfeeding women

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No