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

• Status: Withdrawn
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Galectin Therapeutics Inc.
• Treatments: Bevacizumab; Fluorouracil; Leucovorin

Criteria

Inclusion Criteria:

• 18 years or older.

• Histologically confirmed, unresectable, locally advanced or metastatic colorectal adenocarcinoma (stage III and IV), not amenable to curative surgery or radiotherapy.

• Intolerant of oxaliplatin and/or irinotecan, as demonstrated by unacceptable toxicity after a trial of these agents as first-line therapy, or in the opinion of the Investigator, be judged at high risk for unacceptable toxicity to oxaliplatin and/or irinotecan,

• Presence of at least 1 measurable lesion,

• Have a life expectancy of at least 4 months.

• Women of childbearing potential, have a negative serum pregnancy test at screening and Day 1 treatment and agree to practice abstinence or use an effective method of contraception.

Exclusion Criteria:

• Central nervous system metastasis.

• Bony metastasis as the sole metastasis.

• Received any prior first-line chemotherapy for colorectal cancer.

• Previously exposed to DAVANAT® or Avastin®.

• Known or clinically suspected infection with HIV.

• Participated within 30 days or will participate concurrently in another investigational drug or vaccine study.

• History of drug or alcohol dependence in the past 3 years.

• Other serious, non-malignant, significant, acute or chronic medical or psychiatric illness that in the judgment of the Investigator could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.