A Phase II Study of ZD1839 (Iressa, Gefitinib, NSC 715055) in Advanced Unresectable Hepatocellular Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- gefitinib
- Conditions
- Adult Primary Hepatocellular Carcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Progression-free survival rate in patients treated with ZD 1839
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced unresectable hepatocellular carcinoma (liver cancer). Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the ability of ZD1839 to improve progression free survival in patients with advanced unresectable hepatocellular carcinoma. II. Evaluate response rate of ZD1839 in advanced unresectable hepatocellular carcinoma. III. Evaluate the effect of ZD1839 on measurable disease in patients with unresectable hepatocellular carcinoma. IV. Evaluate the effect of ZD1839 on serum alpha-fetoprotein levels in patients with abnormal pretreatment serum levels. V. Evaluate toxicity of ZD1839 in advanced unresectable hepatocellular carcinoma. VI. Investigate biologic markers for outcome in patients with unresectable hepatocellular carcinoma treated with ZD1839. OUTLINE: This is a multicenter study. Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed for 3 years from study entry.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have advanced unresectable hepatocellular carcinoma based on the following criteria:
- •Histologically or cytologically confirmed, OR
- •Alpha-fetoprotein \> 400 ng if patient is not hepatitis surface antigen positive, OR
- •Alpha-fetoprotein \> 4000 ng if patient is hepatitis surface antigen positive
- •NOTE: If available, tissue should be submitted to assess EGFR/pathway expression
- •Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 20 mm with conventional techniques or as \>= 10 mm with spiral CT scan, assessed within 4 weeks prior to randomization/registration
- •Prior use of liver-directed therapy (radio-frequency ablation, cryoablation, percutaneous ethanol injection, chemo-embolization, hepatic artery embolization and hepatic artery infused FUDR) is allowed, provided the patient has either progressive hepatic disease or measurable extrahepatic disease
- •ECOG performance status of 0, 1 or 2
- •Leukocytes \>= 2,000/uL OR
- •Absolute neutrophil count \>= 1,000/uL
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment (gefitinib)
Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: gefitinib
Treatment (gefitinib)
Patients receive oral gefitinib daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention: laboratory biomarker analysis
Outcomes
Primary Outcomes
Progression-free survival rate in patients treated with ZD 1839
Time Frame: From the date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, assessed up to 4.5 months
A 4.5-month (PFS) rate of 63% or more will be taken as evidence of activity in this patient population.
Secondary Outcomes
- Grade 3 or higher toxicity(Up to 3 years)
- EGFR expression(Baseline)
- Response (CR+PR) measured by RECIST(Up to 3 years)