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

Previously Treated Advanced Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01926769
• Other study ID #: 2012-GIRBA-2675
• Status: Terminated
• Phase: Phase 2
• Start date: February 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2018
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Previously Treated Advanced Colorectal Cancer

Intervention

Drug:
• Metformin

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Control Rate		one year
Secondary	Response Rate		one year
Secondary	Overall Survival		one year
Secondary	Number of participants with adverse events		one year
Secondary	Progression Free Survival		one year