GM-CT-01 Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: A Phase II, Multi-Center, Open-Label Trial to Evaluate the Efficacy and Safety of Intravenous GM-CT-01 in Combination With 5-Fluorouracil When Administered in Monthly Cycles as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

Status Terminated

Clinical Trial Summary

This is a Phase II, multi-center study of GM-CT-01 which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. In this Phase II study, patients with colon cancer which has spread, despite treatment with approved therapies, will receive GM-CT-01 plus 5-FU in monthly cycles for at least 2 cycles or until their disease progresses.

Clinical Trial Description

A Phase I study of 40 patients showed that GM-CT-01 in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments. The main reason for doing this Phase II study in advanced colorectal cancer patients is to verify the safety observations in the early Phase I study and further evaluate the efficacy of these drugs' combination to stabilize tumors, preventing further growth and potentially shrink tumors. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

• NCT number: NCT00110721
• Study type: Interventional
• Source: Galectin Therapeutics Inc.
• Status: Terminated
• Phase: Phase 2
• Start date: May 2005
• Completion date: February 2008