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

Gachon University Gil Medical Center

Status and phase: Terminated; Phase 2

Conditions: Previously Treated Advanced Colorectal Cancer

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01926769

2012-GIRBA-2675

Details and patient eligibility

About

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

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

FOLFOX6+Metformin/FOFIRI+Metformin

Experimental group

Treatment:

Drug: Metformin