Metformin Plus Irinotecan for Refractory Colorectal Cancer

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barretos Cancer Hospital
• Collaborators: AC Camargo Cancer Center; University of Campinas, Brazil
• Treatments: Camptothecin; Irinotecan; Metformin

Criteria

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