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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
metformin up to 2500mg/d
Irinotecan 350 mg/m² IV q21d
Barretos Cancer Hospital
Barretos, São Paulo, Brazil
RECRUITINGState University of Campinas
Campinas, São Paulo, Brazil
NOT_YET_RECRUITINGNon-Progression at week 12th of treatment
Non-Progression at week 12th of treatment
Time frame: 12th week
Progression-free survival
Progression-free survival
Time frame: 12th week
Overall Survival
Overall Survival
Time frame: 12th week
Quality of life
Measured by EORTC QLQ C30
Time frame: 12th week
Safety
Assessment of toxicity according to CTC 4.0
Time frame: 12th week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.