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
Overview[ - collapse ][ - ]
| Purpose | 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 |
|---|---|
| Condition | Previously Treated Advanced Colorectal Cancer |
| Intervention | Drug: Metformin |
| Phase | Phase 2 |
| Sponsor | Gachon University Gil Medical Center |
| Responsible Party | Gachon University Gil Medical Center |
| ClinicalTrials.gov Identifier | NCT01926769 |
| First Received | August 19, 2013 |
| Last Updated | August 19, 2013 |
| Last verified | August 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 19, 2013 |
|---|---|
| Last Updated Date | August 19, 2013 |
| Start Date | February 2012 |
| Estimated Primary Completion Date | Not Provided |
| Current Primary Outcome Measures | Disease Control Rate [Time Frame: one year] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | 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 |
|---|---|
| Official Title | Not Provided |
| 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 Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Previously Treated Advanced Colorectal Cancer |
| Intervention | Drug: Metformin |
| Study Arm (s) | Experimental: FOLFOX6+Metformin/FOFIRI+Metformin |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 48 |
| Estimated Completion Date | Not Provided |
| Estimated Primary Completion Date | January 2015 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01926769 |
|---|---|
| Other Study ID Numbers | 2012-GIRBA-2675 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Gachon University Gil Medical Center |
| Study Sponsor | Gachon University Gil Medical Center |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | August 2013 |
Locations[ + expand ][ + ]
| Gachon University Gil Medical Center | Incheon, Korea, Republic of Contact: Hee Kyung Ahn | +82-32-460-3220Recruiting |
|---|