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

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ClinicalTrials.gov Identifier: NCT00388700
Recruitment Status : Withdrawn (Financing and re-organization)
First Posted : October 17, 2006
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Galectin Therapeutics Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: GM-CT-01 Drug: 5-Fluorouracil, Leukovorin, bevacizumab Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: GM-CT-01 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 .)
Other Name: DAVANAT

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.
Other Name: 5-FU, LV, Avastin®


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: When 17 evaluable patients will complete the study ]
    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.


Secondary Outcome Measures :
  1. To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen. [ Time Frame: Throughout the study and when 17 evaluable patients will when complete the study ]
    Assess safety of regimen and also patient reported outcomes using a Quality of Life (QoL) instrument.

  2. Explore progression-free survival (PFS) and survival [ Time Frame: When at least 17 evaluable patients complete the study ]
    To explore time to tumor progression, duration of response and and survival at 6 and 12 months after the first dose of study drug.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00388700


Locations
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Israel
Rambam Medical Center
Haifa, Israel, 31096
Kaplan MC
Rechovot, Israel
Sheba MC
Tel Hashomer, Israel, 52621
Sourasky Medical Center
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Galectin Therapeutics Inc.
More Information
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Responsible Party: Galectin Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00388700    
Other Study ID Numbers: DAVFU006
First Posted: October 17, 2006    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Keywords provided by Galectin Therapeutics Inc.:
Colorectal cancer, DAVANAT, colon cancer, 5-FU
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Leucovorin
Bevacizumab
Fluorouracil
Antineoplastic Agents, Immunological
 Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Antidotes
Protective Agents
Vitamin B Complex
Vitamins