NCT00388700

A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer

Open-Label, Phase 2 Study of GM-CT-01 When Added to a Regimen of Leucovorin, 5-FU, and Avastin as First Line Treatment for Locally Advanced, Unresectable or Metastatic Colorectal Cancer in Subjects Unable to Tolerate Intensive Chemotherapy

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Galectin Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to determine whether the combination of 5-fluorouracil (5-FU) plus a DAVANAT (carbohydrate polymer) along with Avastin and Leucovorin (LV) is beneficial in treating colorectal cancer in patients unable to tolerate intensive chemotherapy.

Detailed description

This is a Phase II, multi-center study of DAVANAT which has been shown to increase the anti-tumor activity of 5-FU in mice. 5-FU is a chemotherapy drug commonly used to treat tumors. A Phase I study of 40 patients showed that DAVANAT in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	GM-CT-01	On Day 1 and 2 of each cycle, GM-CT-01 280 mg/m2 administered IV over 30 minutes with 5-FU (400 mg/m2), followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) with 5-FU (600 mg/m2 .)
DRUG	5-Fluorouracil, Leukovorin, bevacizumab	On Day 1 and 2 of each cycle, LV (200 mg/m2) will be administered IV over 2 hours, followed by 5-FU 400 mg/m2 in solution with GM-CT-01 280 mg/m2 administered over 30 minutes, followed by a 22-hour continuous infusion of GM-CT-01 (280 mg/m2) and 5-FU (600 mg/m2 ). on Day 3 Avastin® (5 mg/kg)will be given IV over 30 to 90 minutes per the package insert.

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2006-10-17
• Last updated: 2018-02-14

Locations

4 sites across 1 country: Israel