Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.
Overview
- Phase
- Phase 2
- Intervention
- Metformin and Fluorouracil
- Conditions
- Metastatic Colorectal Cancer
- Sponsor
- Instituto do Cancer do Estado de São Paulo
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Disease Control Rate according to RECIST 1.1
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a phase II trial to evaluate efficacy and safety of Metformin and Fluorouracil in patients with metastatic colorectal cancer (CRC) who have progressed after Oxaliplatin and Irinotecan based chemotherapy.
Detailed Description
Primary Outcomes Measures: - Disease control Rate at 8 weeks according to RECIST 1.1 (Tumor response was defined as the percentage of patients with complete response, partial response or stable disease as best overall response). Secondary Outcome Measures: * Progression-free Survival * Overall Survival * Adverse Events (assessed according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0)
Investigators
Vanessa C Miranda
Fellow in Clinical Oncology
Instituto do Cancer do Estado de São Paulo
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Metformin and Flourouracil
Intervention: Metformin and Fluorouracil
Outcomes
Primary Outcomes
Disease Control Rate according to RECIST 1.1
Time Frame: From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 8 week intervals
Secondary Outcomes
- Overall Survival(From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals)
- Adverse Events(From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals.)
- Progression-free Survival(From randomization of the first subject until the database cut-off approximately 12 months later (01Nov2012 up to 01Nov2015). Tumor assessed at 4 week intervals.)