Study to Test the Benefit and Safety of GM-CT-01 in Combination With 5-FU to Treat Bile Duct and Gall Bladder Cancer

NCT ID: NCT00386516

Last Updated: 2017-08-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2009-06-30

Brief Summary

The purpose of this clinical trial is to determine whether the combination of the established chemotherapeutic agent 5-fluorouracil(5-FU) and the large carbohydrate molecule GM-CT-01 is beneficial in treating advanced gall bladder and bile duct cancer.

Detailed Description

Determine the overall response rate (ORR) defined as complete response (CR)rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST), as well as the stable disease (SD) rate in subjects with unresectable, locally advanced or metastatic cholangiocarcinoma or other biliary tract tumors treated with GM-CT-01 plus 5-Fluorouracil (DAVFU) at doses of 280 mg/m2 and 600 mg/m2, respectively, during cycles of 4 consecutive days of treatment followed by a 24-day follow-up period.

Conditions

Cancer of the Bile Duct; Gallbladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GM-CT-01, 5-FU

GM-CT-01 (280 mg/m2) combined with 5-FU (600 mg/m2) given 4 consecutive days in a 28 days cycle until disease progression.

Group Type: EXPERIMENTAL

GM-CT-01

Intervention Type: DRUG

GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression

5-Fluorouracil

Intervention Type: DRUG

5-FU given IV by infusion for 30, at 600 mg/m2 in combination with GM-CT-01 for 4 consecutive days in 28 days cycle until disease progression

Interventions

GM-CT-01

GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression

Intervention Type: DRUG

5-Fluorouracil

5-FU given IV by infusion for 30, at 600 mg/m2 in combination with GM-CT-01 for 4 consecutive days in 28 days cycle until disease progression

Intervention Type: DRUG

Other Intervention Names

DAVANAT; 5-FU

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or older.

2. Histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.

3. Prior neo-adjuvant or adjuvant therapy (including radiation therapy) is allowed provided it was completed at least 4 weeks before documented disease recurrence or metastasis.

4. Discontinuation of radiation therapy at least 3 weeks prior to Day 1 of Cycle 1. Radiation therapy will not be allowed while a subject is on study except for palliative radiation therapy to non-target lesions administered following consultation with the Medical Monitor.

5. Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.

6. Nne or more measurable target lesion(s) according to RECIST. Measurable lesion(s) must be outside of previous radiation field or demonstrate clear radiographic progression on serial imaging if within previous treatment field.

7. ECOG performance status less than or equal to 2.

8. Life expectancy greater or equal to 3 months.

Exclusion Criteria

1. Central nervous system metastasis.

2. Bony metastasis as the sole metastasis.

3. Received prior chemotherapy or anti-angiogenesis agents including bevacizumab or erbitux or radiation therapy other than in a neo-adjuvant or adjuvant setting. No concomitant chemotherapy, anti-tumor biologic therapy, or radiation therapy is allowed.

4. If nitrosoureas or mitomycin C were used as neo-adjuvant or adjuvant therapy, then at least 6 weeks should have elapsed prior to treatment with DAVFU.

5. Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy.

6. Congestive heart failure (Class III or IV in the NYHA functional classification system) or any other medical condition that would preclude the IV administration of up to approximately 200 mL of fluid over 30-60 minutes.

7. Unresolved biliary tract obstruction.

8. Known or clinically suspected infection with HIV.

9. Subject has a known intolerance to 5- FU.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galectin Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Boston Medical Center

Boston, Massachusetts, United States

University of Michigan, Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Barrett Cancer Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

DAVFU-007

Identifier Type: -

Identifier Source: org_study_id