Clinical trial · Interventional
Metformin Plus Irinotecan for Refractory Colorectal Cancer
Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer
NCT01930864CI-TRIAL-00028217unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan | Drug | Irinotecan | ALIAS |
| metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- metfomin + irinotecan
- description
- Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal
- interventionNames
- Drug: metformin
- Drug: irinotecan
Primary outcomes (1)
- measure
- Non-Progression at week 12th of treatment
- timeFrame
- 12th week
- description
- Non-Progression at week 12th of treatment
Secondary outcomes (4)
- measure
- Progression-free survival
- timeFrame
- 12th week
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDRocha GZ, Dias MM, Ropelle ER, Osorio-Costa F, Rossato FA, Vercesi AE, Saad MJ, Carvalheira JB. Metformin amplifies chemotherapy-induced AMPK activation and antitumoral growth. Clin Cancer Res. 2011 Jun 15;17(12):3993-4005. doi: 10.1158/1078-0432.CCR-10-2243. Epub 2011 May 4. PMID 21543517