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

Purpose

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.

Condition	Intervention	Phase
Cancer of the Bile Duct Gallbladder Cancer	Drug: GM-CT-01 Drug: 5-Fluorouracil	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Cancer

Drug Information available for: Fluorouracil

U.S. FDA Resources

Further study details as provided by Galectin Therapeutics Inc.:

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) [ Time Frame: When 18 valuable patients have completed 2nd CT ] [ Designated as safety issue: No ]
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 [ Time Frame: When 18 valuable patients have completed 2nd CT ] [ Designated as safety issue: No ]
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) [ Time Frame: Any patient completed a drug treatment ] [ Designated as safety issue: Yes ]

Enrollment:	17
Study Start Date:	September 2006
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Drug: GM-CT-01 GM-CT-01 at 280 mg/m2 given IV for 4 consecutive days in 28 days cycle until disease progression Other Name: DAVANAT 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 Other Name: 5-FU

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386516

Locations

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan, Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
United States, Ohio
Barrett Cancer Center
Cincinnati, Ohio, United States, 45267-0501

Sponsors and Collaborators

Galectin Therapeutics Inc.

More Information

No publications provided

Responsible Party:	Galectin Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00386516 History of Changes
Other Study ID Numbers:	DAVFU-007
Study First Received:	October 10, 2006
Last Updated:	March 13, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Galectin Therapeutics Inc.:

cholangiocarcinoma
bile duct
biliary
intra-hepatic
extra-hepatic
gall bladder

cancer
carcinoma
metastatic
metastasis
advanced
recurrent

Additional relevant MeSH terms:

Gallbladder Neoplasms
Bile Duct Neoplasms
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Bile Duct Diseases

Fluorouracil
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013