Metformin and 5-fluorouracil for Refractory Colorectal Cancer.

Phase 2

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Metformin and Fluorouracil

• Registration Number: NCT01941953
• Lead Sponsor: Instituto do Cancer do Estado de São Paulo

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)

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Primary Completion: 2014-11
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin and Flourouracil	Metformin and Fluorouracil	-

Primary Outcome Measures

Name	Time	Method
Disease Control Rate according to RECIST 1.1	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 Outcome Measures

Name	Time	Method
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	defined as time from first dose of treatment until death, with date of last visit being considered censorship
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.	defined as time from randomization to death from any cause, or even radiological detection/or clinical of disease progression, increased CEA will not be considered isolated progression.

Trial Locations

Locations (1)

Instituto Do Cancer Do Estado de São Paulo; 🇧🇷 Sao Paulo, Brazil