Clinical trial · Interventional
A Phase II Study to Determine the Safety and Efficacy of Second-line Treatment With Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the Second Line Threatment of Advanced Colorectal Cancer
NCT01926769CI-TRIAL-00032929terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual rate
Summary
Brief summary (as posted)
To determine the safety and efficacy of second-line treatment with Metformin and Chemotherapy (FOLFOX6 or FOFIRI) in the second line treatment of advanced colorectal cancer
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 |
|---|---|---|---|
| Previously Treated Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FOLFOX6+Metformin/FOFIRI+Metformin
- interventionNames
- Drug: Metformin
Primary outcomes (1)
- measure
- Disease Control Rate
- timeFrame
- one year
Secondary outcomes (4)
- measure
- Response Rate
- timeFrame
- one year
- measure
- Overall Survival
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age over 18 * histologically confirmted advanced colorectal cancer * ECOG PS 0-2 * expected life span more than 3months * normal bone marrow, liver, renal function Exclusion Criteria: * 5-FU, oxaliplatin, irinotecan or Metformin Allergic history * Lactic acidosis, metabolic acidosis * active infection or severe neuropathy
References
Publications (0)
Data not yet available
No reference posted for this study.