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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926769

Enrollment

Registered

2013-08-21

Start date

2012-02-29

Completion date

2014-12-31

Last updated

2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously Treated Advanced Colorectal Cancer

Keywords

Colorectal cancer, Metformin, FOLFOX6, FOFIRI, 5FU, irinotecan, oxaliplatin

Brief summary

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

Interventions

DRUGMetformin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Disease Control Rate	one year

Secondary

Measure	Time frame
Number of participants with adverse events	one year
Progression Free Survival	one year
Response Rate	one year
Overall Survival	one year

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026