NCT01941953

Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

Phase II Study of Metformin and 5-fluorouracil in Patients With Advanced Colorectal Cancer Previously Treated With Oxaliplatin and Irinotecan Based Chemotherapy.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Metformin and Fluorouracil	metformin 850mg PO BID plus 5FU 425mg/m2 + leucovorin 50mg IV weekly

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-11-01
• Completion: 2015-03-01
• First posted: 2013-09-13
• Last updated: 2015-04-08

Locations

1 site across 1 country: Brazil