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

NCT00388700 | Withdrawn Phase 2

• 1 other identifier: DAVFU006
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Colorectal Cancer

Keywords

Colorectal cancer, DAVANAT, colon cancer, 5-FU

Outcome Measures

Primary Outcomes (1)

• Primary Outcomes: Assess the efficacy and safety of GM-CT-01 administered with 5-FU, LV, and Avastin® in the first-line treatment of unresectable, locally advanced, and/or metastatic CRC.

  To assess the clinical benefit of a regimen of GM-CT-01/5-FU, LV plus Avastin® when administered intravenously as a first-line treatment to patients with Stage III or IV ,advanced or metastatic CRC. Clinical activity will be assessed by determining the percentage of subjects exhibiting an objective response (complete response \[CR\]) plus partial response \[PR\]). Tumor response will be assessed following Response Evaluation by RECIST guidelines.

  When 17 evaluable patients will complete the study

Secondary Outcomes (2)

• To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen.

  Throughout the study and when 17 evaluable patients will when complete the study

• Explore progression-free survival (PFS) and survival

  When at least 17 evaluable patients complete the study

Study Arms (1)

GM-CT-01

EXPERIMENTAL

Drug: GM-CT-01; Drug: 5-Fluorouracil, Leukovorin, bevacizumab

Interventions

GM-CT-01 DRUG

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 .)

Also known as: DAVANAT

GM-CT-01

5-Fluorouracil, Leukovorin, bevacizumab DRUG

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.

Also known as: 5-FU, LV, Avastin®

GM-CT-01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galectin Therapeutics Inc.: lead

Study Sites (4)

Rambam Medical Center

Haifa, 31096, Israel

Location

Kaplan MC

Rehovot, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Sheba MC

Tel Litwinsky, 52621, Israel

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

galactomannan; Fluorouracil; Leucovorin; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2006
• First Posted: October 17, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: February 14, 2018

Record last verified: 2018-02

Locations

IL (4)