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

NCT00386516 | Withdrawn Phase 2

• 1 other identifier: DAVFU-007
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer of the Bile Duct; Gallbladder Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  When 18 valuable patients have completed 2nd CT

• 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.

  When 18 valuable patients have completed 2nd CT

Secondary Outcomes (1)

• Safety, tolerability and Quality of Life (QoL)

  Any patient completed a drug treatment

Study Arms (1)

GM-CT-01, 5-FU

EXPERIMENTAL

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; Drug: 5-Fluorouracil

Interventions

GM-CT-01 DRUG

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

Also known as: DAVANAT

GM-CT-01, 5-FU

5-Fluorouracil 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

Also known as: 5-FU

GM-CT-01, 5-FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Galectin Therapeutics Inc.: lead

Study Sites (3)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Michigan, Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Barrett Cancer Center

Cincinnati, Ohio, 45267-0501, United States

Location

MeSH Terms

Conditions

Bile Duct Neoplasms; Gallbladder Neoplasms; Cholangiocarcinoma; Neoplasms; Carcinoma; Neoplasm Metastasis; Recurrence

Interventions

galactomannan; Fluorouracil

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2006
• First Posted: October 11, 2006
• Study Start: September 1, 2006
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 1, 2017

Record last verified: 2014-08

Locations

US (3)