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

NCT ID: NCT01926769

Last Updated: 2018-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Previously Treated Advanced Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOLFOX6+Metformin/FOFIRI+Metformin

Group Type EXPERIMENTAL

Metformin

Intervention Type DRUG

Interventions

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Metformin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hee Kyung Ahn

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gachon University Gil Medical Center

Incheon, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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2012-GIRBA-2675

Identifier Type: -

Identifier Source: org_study_id

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