Adenocarcinoma, Colorectal Neoplasms
Conditions
Keywords
metformin, colorectal cancer, chemotherapy
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.
Interventions
DRUGmetformin
metformin up to 2500mg/d
DRUGirinotecan
Irinotecan 350 mg/m² IV q21d
Sponsors
University of Campinas, Brazil
AC Camargo Cancer Center
Barretos Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-Progression at week 12th of treatment | 12th week | Non-Progression at week 12th of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 12th week | Progression-free survival |
| Overall Survival | 12th week | Overall Survival |
| Quality of life | 12th week | Measured by EORTC QLQ C30 |
| Safety | 12th week | Assessment of toxicity according to CTC 4.0 |
Countries
Brazil
Contacts
Primary ContactJoao Paulo SN Lima, MD
Backup ContactArinilda C Bragagnoli, MD
Outcome results
None listed