Metformin Plus Irinotecan for Refractory Colorectal Cancer

Phase 2

• Conditions: Adenocarcinoma; Colorectal Neoplasms
• Interventions: Drug: metformin; Drug: irinotecan

• Registration Number: NCT01930864
• Lead Sponsor: Barretos Cancer Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-08-26
• Study First Posted: 2013-08-29
• Study Start: 2015-09-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-21
• Last Update Posted: 2017-06-22
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 41

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Non-Progression at week 12th of treatment	12th week	Non-Progression at week 12th of treatment

Secondary Outcome Measures

Name	Time	Method
Overall Survival	12th week	Overall Survival
Progression-free survival	12th week	Progression-free survival
Quality of life	12th week	Measured by EORTC QLQ C30
Safety	12th week	Assessment of toxicity according to CTC 4.0

Trial Locations

Locations (2)

Barretos Cancer Hospital; 🇧🇷 Barretos, SP, Brazil

State University of Campinas; 🇧🇷 Campinas, São Paulo, Brazil