Back to resultsA 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
Primary Purpose
Previously Treated Advanced Colorectal Cancer
Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Previously Treated Advanced Colorectal Cancer focused on measuring Colorectal cancer, Metformin, FOLFOX6, FOFIRI, 5FU, irinotecan, oxaliplatin
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
Sites / Locations
- Gachon University Gil Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FOLFOX6+Metformin/FOFIRI+Metformin
Arm Description
Outcomes
Primary Outcome Measures
Disease Control Rate
Secondary Outcome Measures
Response Rate
Overall Survival
Number of participants with adverse events
Progression Free Survival
Full Information
NCT ID
NCT01926769
First Posted
August 19, 2013
Last Updated
May 9, 2018
Sponsor
Gachon University Gil Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01926769
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual rate
Study Start Date
February 2012 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Previously Treated Advanced Colorectal Cancer
Keywords
Colorectal cancer, Metformin, FOLFOX6, FOFIRI, 5FU, irinotecan, oxaliplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FOLFOX6+Metformin/FOFIRI+Metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Primary Outcome Measure Information:
Title
Disease Control Rate
Time Frame
one year
Secondary Outcome Measure Information:
Title
Response Rate
Time Frame
one year
Title
Overall Survival
Time Frame
one year
Title
Number of participants with adverse events
Time Frame
one year
Title
Progression Free Survival
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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
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