Clinical trial · Interventional
Metformin and 5-fluorouracil for Refractory Colorectal Cancer.
Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.
NCT01941953CI-TRIAL-00017432completedPhase 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)
This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and Irinotecan based chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin and Fluorouracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Metformin and Flourouracil
- interventionNames
- Drug: Metformin and Fluorouracil
Primary outcomes (1)
- measure
- Disease Control Rate according to RECIST 1.1
- timeFrame
- From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 8 week intervals
Secondary outcomes (3)
- measure
- Progression-free Survival
- timeFrame
- From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals.
- description
- defined as time from randomization to death from any cause, or even radiological detection/or clinical of disease progression, increased CEA will not be considered isolated progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria * Histological diagnosis of metastatic colorectal adenocarcioma previously treated with at least two lines of chemotherapy (oxaliplatin and irinotecan regimens) if mutated KRAS or treated with at least 3 lines of chemotherapy (oxaliplatin, irinotecan and cetuximab) if KRAS wild type. * Disease progression according to radiological or clinical assessment. * Measurable disease. * ECOG Performance 0-1. * Age above 16 years. * Normal organic function as defined for the following criteria: * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 times the upper normal limit of the local laboratory (LSN-LL); * Total serum bilirubin ≤ 2.0 x ULN-LL; * Absolute neutrophil count ≥ 1,500 / mm3; * Platelet count ≥ 100,000 / mm3; * Hemoglobin ≥ 8.0 g / dl; * Serum creatinine ≤ 1.5 x ULN-LL * Written informed consent before enrollment Exclusion Criteria * Diabetic patients taking metformin. * Patients already treated with mTOR inhibitors. * Hypersensitivity to metformin, renal or hepatic impairment or other conditions that predispose to lactic acidosis. * History of acute myocardial infarction in the last 6 months * Serious illness or psychiatric condition. * Current participation in other protocols with experimental drugs. * Suspicion of dihidropirimida dehydrogenase(DPD)deficiency. * Presence of active infection. * No ability to ingest food orally. * Patients with metastatic disease to CNS. * Patients who underwent major surgery in the last 4 weeks. * Patients who received chemotherapy in the last three weeks. * Patients who underwent radiotherapy in the last 2 weeks or who received radiotherapy in the target lesion, if this is the only target lesion. * Patients using oral anticoagulation (warfarin). * Pregnant or lactating patients
References
Publications (0)
Data not yet available
No reference posted for this study.