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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00071994 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have advanced unresectable hepatocellular carcinoma (liver cancer ).
Condition | Intervention | Phase |
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Liver Cancer |
Drug: gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of ZD1839 (Iressa, Gefitinib, NSC 715055) In Advanced Unresectable Hepatocellular Carcinoma |
Study Start Date: | February 2004 |
Estimated Primary Completion Date: | February 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 23-59 patients will be accrued for this study within 19 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of advanced unresectable hepatocellular carcinoma based on 1 of the following criteria:
At least 1 unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent inducers of CYP3A4, including the following:
Study Chair: | Bruce J. Giantonio, MD | Presbyterian Medical Center |
Investigator: | Jordan D. Berlin, MD | Vanderbilt-Ingram Cancer Center |
Investigator: | Peter J. O'Dwyer, MD, BCh | University of Pennsylvania |
Study ID Numbers: | CDR0000335058, ECOG-E1203 |
Study First Received: | November 4, 2003 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00071994 History of Changes |
Health Authority: | United States: Federal Government |
advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Protein Kinase Inhibitors Recurrence Carcinoma Liver Neoplasms |
Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Gefitinib Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Gefitinib Neoplasms, Glandular and Epithelial |