Metformin for the Treatment of MCRC Patients Undergoing FOLFIRI Plus Target Therapy

Metformin As an Adjunctive Therapy for the Treatment of Metastatic Colorectal Cancer Patients Undergoing FOLFIRI Plus Target Therapy

To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

Study Overview

• Status: Recruiting
• Conditions: Progression-Free Survival
• Intervention / Treatment: Drug: Metformin Pill; Drug: FOLFIRI plus target therapy only

Detailed Description

Objectives:

1. Main purpose

   • To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

2. Secondary purpose (1) To investigate the survival (OS) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin (2) To investigate the disease control rate (DCR) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 807
    • Recruiting
    • Chung-Ho Memorial Hospital, Kaohsiung Medical University:
    • Contact: Jaw-Yuan Wang, PhD; Phone Number: 5575 +88673121101; Email: cy614112@ms14.hinet.net
    • Contact: Wei-Chih Su, MS; Phone Number: 5575 +88673121101; Email: lake0126@yahoo.com.tw
    • Contact: Jaw-Yuan Wang, Ph.D.
    • Contact: Jaw-Yuan Wang, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged between 20 and 90 years old
2. Patients diagnosed with metastatic colorectal cancer who is going to receive FOLFIRI chemotherapy
3. Female must not be planning to become pregnant or breastfeeding, and not pregnant at any point during treatment. (Contraception is required to participate in this trial)
4. Those without major physiological diseases (example of major cardiovascular disease is acute myocardial infarction; example of major cerebrovascular disease is acute stroke, malignant hypertension, acute kidney failure, acute liver failure)
5. Those who are not allergic to the relevant drugs required for the test
6. Those who can follow the doctor's order to take the medicine
7. Subjects must be willing to sign the consent form
8. Blood sugar level above 80 mg/dL

Exclusion Criteria:

Subjects who meet any of the following exclusion conditions are not allowed to join the trial

1. Patients other than the above-mentioned main inclusion criteria.
2. Non-native speakers
3. Known allergy to metformin or any of its components.
4. Severe instability in diabetes (ketoacidosis).
5. Blood sugar level lower than 80 mg/dL
6. Heart failure, respiratory insufficiency.

7. inadequate hematopoietic function defined as below:

   • hemoglobin < 9 g/dL;
   • absolute neutrophil count (ANC) < 1,500/mm3;
   • platelet count < 100,000/mm3;

8. inadequate organ functions defined as below:

   • total bilirubin > 2 times upper limit of normal (ULN);
   • hepatic transaminases (ALT and AST) > 2.5 x ULN;
   • creatinine > 1.5 x ULN;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group; Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy	Drug: Metformin Pill; Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy; Other Names: Glucophage
Placebo Comparator: Control group; FOLFIRI (Leucovorin (LV), 200 mg/m2, 2-hour infusion, 5-FU, 2,800 mg/m2, 46-hour infusion, Irinotecan (IRI), 180 mg/m2, 2-hour infusion) plus target therapy	Drug: FOLFIRI plus target therapy only; FOLFIRI (Leucovorin (LV), 200 mg/m2, 2-hour infusion, 5-FU, 2,800 mg/m2, 46-hour infusion, Irinotecan (IRI), 180 mg/m2, 2-hour infusion) plus target therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression-free survival (PFS)	Disease progression-free survival (PFS) was defined as the date from the initiation of trial treatment until the date of the first imaging-confirmed progression or death (whichever occurred first)	The trial will continue to follow (approximately every 4 weeks) the subject's survival status until death, loss of follow-up, end of trial, or termination of the trial, assessed up to 52 months

Collaborators and Investigators

• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: January 27, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: KMUHIRB-F(I)-20220106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared. Results will be published by the investigators in academic journals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No