Metformin Plus Irinotecan for Refractory Colorectal Cancer

Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer

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

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.

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