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

2014-08-27 03:42:07 | BioPortfolio

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 DAVANAT is beneficial in treating advanced gall bladder and bile duct cancer.

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 DAVANAT 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.

Study Design

Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Cancer of the Bile Duct

Intervention

DAVANAT in combination with 5-Fluorouracil

Location

Boston Medical Center
Boston
Massachusetts
United States
02118

Status

Active, not recruiting

Source

Pro-Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:07-0400

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DAVANAT Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

This is a Phase II, multi-center study of a carbohydrate (DAVANAT) which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug co...

Radiation Therapy and Fluorouracil Before Surgery in Treating Patients With Primary or Recurrent Bile Duct Cancer

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A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures

The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to t...

Photodynamic Therapy in Treating Patients With Cancer of the Bile Duct, Gallbladder, or Pancreas

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PubMed Articles [14125 Associated PubMed Articles listed on BioPortfolio]

Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: Extrahepatic Bile Duct Preserving or Not? Reply.

Retroperitoneal bile leak after laparoscopic cholecystectomy.

Bile duct injury (BDI) is a well-recognised complication of laparoscopic cholecystectomy (LC). Following a BDI, bile usually leaks into the peritoneal space and causes biliary peritonitis. This manife...

Ultra-early occlusion of the normal bile duct after uncovered self-expandable metallic stent placement in unresectable perihilar bile duct cancer.

Uncovered self-expandable metallic stents (USEMS) are superior to plastic stents in patients with unresectable malignant perihilar biliary obstruction (UMHBO). The causes of SEMS occlusion include: tu...

Novel use of a balloon dilatation catheter to enable mechanical lithotripsy of difficult common bile duct stones after initial failed attempt: A case report.

Difficult and large common bile duct stones can be crushed and removed using a mechanical lithotripter. Very often the lack of working space within the common bile duct causing the failure of mechanic...

Eversion Bile Duct Anastomosis: A Safe Alternative for Bile Duct Size Discrepancy in Deceased Donor Liver Transplantation.

Introduction Bile duct size discrepancy in liver transplantation may increase the risk of biliary complications. The aim of this study was to evaluate the safety and outcomes of the eversion bile duct...

Medical and Biotech [MESH] Definitions

Tumor or cancer of the COMMON BILE DUCT including the AMPULLA OF VATER and the SPHINCTER OF ODDI.

Adenocarcinoma of the common hepatic duct bifurcation. These tumors are generally small, sharply localized, and seldom metastasizing. G. Klatskin's original review of 13 cases was published in 1965. Once thought to be relatively uncommon, tumors of the bifurcation of the bile duct now appear to comprise more than one-half of all bile duct cancers. (From Holland et al., Cancer Medicine, 3d ed, p1457)

Tumors or cancer of the BILE DUCTS.

A congenital anatomic malformation of a bile duct, including cystic dilatation of the extrahepatic bile duct or the large intrahepatic bile duct. Classification is based on the site and type of dilatation. Type I is most common.

The largest bile duct. It is formed by the junction of the CYSTIC DUCT and the COMMON HEPATIC DUCT.

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