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

Primary Purpose

Cancer of the Bile Duct, Gallbladder Cancer

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

GM-CT-01

5-Fluorouracil

About this trial

This is an interventional treatment trial for Cancer of the Bile Duct focused on measuring cholangiocarcinoma, bile duct, biliary, intra-hepatic, extra-hepatic, gall bladder, cancer, carcinoma, metastatic, metastasis, advanced, recurrent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 years of age or older.
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.
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.
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.
Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1.
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.
ECOG performance status less than or equal to 2.
Life expectancy greater or equal to 3 months.

Exclusion Criteria:

Central nervous system metastasis.
Bony metastasis as the sole metastasis.
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.
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.
Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy.
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.
Unresolved biliary tract obstruction.
Known or clinically suspected infection with HIV.
Subject has a known intolerance to 5- FU.

Sites / Locations

Boston Medical Center
University of Michigan, Comprehensive Cancer Center
Barrett Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GM-CT-01, 5-FU

Arm Description

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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST)

A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. CR, PR, SD and progressive disease (PD) as defined by RECIST criteria.

Stable disease (SD) rate and progression-free survival (PFS) times

A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. SD and progressive disease (PD) as defined by RECIST criteria.

Secondary Outcome Measures

Safety, tolerability and Quality of Life (QoL)

Full Information

NCT ID

NCT00386516

First Posted

October 10, 2006

Last Updated

July 31, 2017

Sponsor

Galectin Therapeutics Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00386516

Brief Title

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

Official Title

Phase 2, Multi-center, Open-label Trial to Evaluate Efficacy and Safety of GM-CT-01 in Combination With 5-FU as First Line Chemotherapy in Patients With Advanced Biliary Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Withdrawn

Why Stopped

Financing and re-organization

Study Start Date

September 2006 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galectin Therapeutics Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer of the Bile Duct, Gallbladder Cancer

Keywords

cholangiocarcinoma, bile duct, biliary, intra-hepatic, extra-hepatic, gall bladder, cancer, carcinoma, metastatic, metastasis, advanced, recurrent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GM-CT-01, 5-FU

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

GM-CT-01

Other Intervention Name(s)

DAVANAT

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

5-Fluorouracil

Other Intervention Name(s)

5-FU

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective response rate (ORR) defined as complete response (CR) rate plus partial response (PR) rate using Response Evaluation Criteria in Solid Tumors (RECIST)

Description

Time Frame

When 18 valuable patients have completed 2nd CT

Title

Stable disease (SD) rate and progression-free survival (PFS) times

Description

A minimum of 18 subjects who meet the response evaluation criteria (per protocol population) will be enrolled in Stage 1. This require 2nd CT evaluation of tumor after minimum 2 cycles of treatments. SD and progressive disease (PD) as defined by RECIST criteria.

Time Frame

When 18 valuable patients have completed 2nd CT

Secondary Outcome Measure Information:

Title

Safety, tolerability and Quality of Life (QoL)

Time Frame

Any patient completed a drug treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 years of age or older. 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. 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. 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. Prior surgery must have been completed at least 14 days prior to Day 1 of Cycle 1. 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. ECOG performance status less than or equal to 2. Life expectancy greater or equal to 3 months. Exclusion Criteria: Central nervous system metastasis. Bony metastasis as the sole metastasis. 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. 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. Active infection that requires treatment with systemic antibiotic, anti- fungal. or anti-viral therapy. 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. Unresolved biliary tract obstruction. Known or clinically suspected infection with HIV. Subject has a known intolerance to 5- FU.

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

University of Michigan, Comprehensive Cancer Center

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Barrett Cancer Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0501

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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