Spots Global Cancer Trial Database for Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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