Clinical trial NCT00388700: A New Agent GM-CT-01 in Combination With 5-FU, Avastin and Leucovorin in Subjects With Colorectal Cancer
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colorectal cancer, DAVANAT, colon cancer, 5-FU
Lead sponsor: Galectin Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: When 17 evaluable patients will complete the study
Secondary outcomes:
measure: To evaluate the safety of the DAVANAT®/5-FU, LV plus Avastin® regimen.
timeFrame: Throughout the study and when 17 evaluable patients will when complete the study
measure: Explore progression-free survival (PFS) and survival
timeFrame: When at least 17 evaluable patients complete the study
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Rechovot
country: Israel
facility: Kaplan MC
city: Tel Hashomer
country: Israel
facility: Sheba MC
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
References: