Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer

Advanced Adult Primary Liver Cancer Clinical Trial

Official title: A Phase II Trial of OSI-774 in Patients With Hepatocellular or Biliary Carcinoma

Status Completed

Clinical Trial Summary

Phase II trial to study the effectiveness of erlotinib in treating patients who have unresectable liver, bile duct, or gallbladder cancer. Biological therapies such as erlotinib may interfere with the growth of cancer cells and slow the growth of the tumor.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To evaluate the proportion of patients with unresectable hepatocellular or biliary carcinoma treated with OSI-774 who are progression-free at 24 weeks.

SECONDARY OBJECTIVES:

I. To evaluate the toxicity profile of this treatment in each of the patient groups.

II. To evaluate the objective response rate of patients with hepatocellular or biliary carcinoma treated with OSI-774.

III. To evaluate overall and progression-free survival. IV. To assess the EGFR protein levels and explore their association with clinical outcome.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 groups according to cancer type (hepatocellular vs biliary).

Patients receive oral erlotinib once daily. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for up to 3 years. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adult Primary Cholangiocellular Carcinoma
• Adult Primary Hepatocellular Carcinoma
• Advanced Adult Primary Liver Cancer
• Bile Duct Neoplasms
• Carcinoma
• Carcinoma, Hepatocellular
• Cholangiocarcinoma
• Cholangiocarcinoma of the Extrahepatic Bile Duct
• Cholangiocarcinoma of the Gallbladder
• Gallbladder Neoplasms
• Liver Neoplasms
• Localized Unresectable Adult Primary Liver Cancer
• Recurrent Adult Primary Liver Cancer
• Recurrent Extrahepatic Bile Duct Cancer
• Recurrent Gallbladder Cancer
• Unresectable Extrahepatic Bile Duct Cancer
• Unresectable Gallbladder Cancer

• NCT number: NCT00033462
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: March 2002