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 2TerminatedNCT01926769

Gachon University Gil Medical Center2 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Previously Treated Advanced Colorectal Cancer

Interventions

MetforminDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Gachon University Gil Medical Center

Incheon, South Korea

Outcomes

Primary Outcomes

Disease Control Rate

Time frame: one year

Secondary Outcomes

Response Rate

Time frame: one year

Overall Survival

Time frame: one year

Number of participants with adverse events

Time frame: one year

Progression Free Survival

Time frame: one year

Data from ClinicalTrials.gov

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