Metformin Plus Irinotecan for Refractory Colorectal Cancer

Barretos Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: Colorectal Neoplasms; Adenocarcinoma

Treatments: Drug: irinotecan; Drug: metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01930864

MetIri

Details and patient eligibility

About

MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.

Full description

MetIri is a two-stage single arm Phase II assessing the role of combination of metformin to irinotecan for colorectal cancer patients already treat with oxaliplatin, fluoropyrimidine, irinotecan and an anti-EGFr antibody if KRAS wild-type.

Enrollment: 41 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or older
• Biopsy-proven colorectal adenocarcinoma
• Ineligibility for curative intent therapy, e.g., surgery or radiation
• Disease progression after oxaliplatin (either adjuvant or palliative), fluoropyrimidine (either adjuvant or palliative), irinotecan, and if Kras wild type a anti-EGFR therapy
• Assessable disease according to RECIST v1.1

Exclusion criteria

• known hypersensitivity to metformin or irinotecan
• Uncontrolled Central nervous system metastasis
• Acute or chronic severe infection

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

metfomin + irinotecan

Experimental group

Description:

Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal

Treatment:

Drug: metformin

Drug: irinotecan