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

Phase 2

Terminated

• Conditions: Previously Treated Advanced Colorectal Cancer
• Interventions: Drug: Metformin

• Registration Number: NCT01926769
• Lead Sponsor: Gachon University Gil Medical Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-08-19
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-21
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FOLFOX6+Metformin/FOFIRI+Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
Disease Control Rate	one year

Secondary Outcome Measures

Name	Time	Method
Response Rate	one year
Overall Survival	one year
Number of participants with adverse events	one year
Progression Free Survival	one year

Trial Locations

Locations (1)

Gachon University Gil Medical Center; 🇰🇷 Incheon, Korea, Republic of