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

Kaohsiung Medical University

Status and phase: Enrolling; Phase 2

Conditions: Progression-Free Survival

Treatments: Drug: Metformin Pill; Drug: FOLFIRI plus target therapy only

Study type: Interventional

Funder types: Other

Identifiers

NCT06826092

KMUHIRB-F(I)-20220106

Details and patient eligibility

About

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

Full 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

Enrollment: 110 estimated patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups, including a placebo group

Study group

Experimental group

Description:

Metformin 500mg TID、FOLFIRI (Leucovorin 200 mg/m2、5-FU 2800 mg/m2、Irinotecan 180 mg/m2) plus target therapy

Treatment:

Drug: Metformin Pill

Control group

Placebo Comparator group

Description:

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

Treatment:

Drug: FOLFIRI plus target therapy only