Dolastatin 10 in Treating Patients With Metastatic Or Recurrent Liver, Bile Duct, or Gallbladder Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer.
OBJECTIVES: I. Determine the objective response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.
OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-35 evaluable patients will be accrued for this study within 9 months.
Primary Purpose: Treatment
Extrahepatic Bile Duct Cancer
University of Illinois at Chicago
Active, not recruiting
National Cancer Institute (NCI)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00003557
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
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.
Hepatic Duct, Common
Predominantly extrahepatic bile duct which is formed by the junction of the right and left hepatic ducts, which are predominantly intrahepatic, and, in turn, joins the cystic duct to form the common bile duct.
Bile Ducts, Extrahepatic
Passages external to the liver for the conveyance of bile. These include the COMMON BILE DUCT and the common hepatic duct (HEPATIC DUCT, COMMON).
Liver Cirrhosis, Biliary
FIBROSIS of the hepatic parenchyma due to obstruction of BILE flow (CHOLESTASIS) in the intrahepatic or extrahepatic bile ducts (BILE DUCTS, INTRAHEPATIC; BILE DUCTS, EXTRAHEPATIC). Primary biliary cirrhosis involves the destruction of small intra-hepatic bile ducts and bile secretion. Secondary biliary cirrhosis is produced by prolonged obstruction of large intrahepatic or extrahepatic bile ducts from a variety of causes.
Common Bile Duct Neoplasms
Tumor or cancer of the COMMON BILE DUCT including the AMPULLA OF VATER and the SPHINCTER OF ODDI.
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