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
- 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
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie Metformin's efficacy in combination with FOLFOX6 or FOFIRI for advanced colorectal cancer?
How does Metformin combination therapy compare to standard second-line treatments for RAS-mutant colorectal cancer in terms of progression-free survival and toxicity profiles?
Are there specific biomarkers such as AMPK activation status or metabolic signatures that predict response to Metformin-based second-line therapy in metastatic colorectal cancer patients?
What are the potential adverse event profiles and management strategies for Metformin combined with oxaliplatin or irinotecan-based chemotherapy regimens in previously treated CRC patients?
What evidence exists for Metformin's role in enhancing chemosensitivity through mTOR pathway modulation in KRAS wild-type colorectal cancer subtypes?
Trial Locations
- Locations (1)
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Gachon University Gil Medical Center🇰🇷Incheon, Korea, Republic of