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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00293436 |
RATIONALE: Celecoxib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth. Celecoxib may also stop the growth of liver cancer by blocking blood flow to the tumor.
PURPOSE: This phase I/II trial is studying the side effects and best dose of giving celecoxib together with erlotinib and to see how well they work in treating patients with liver cancer.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: celecoxib Drug: erlotinib hydrochloride Procedure: adjuvant therapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of Celecoxib and Erlotinib Hydrochloride as Adjuvant Therapy for High Risk Patients With a History of Hepatocellular Carcinoma |
Estimated Enrollment: | 50 |
Study Start Date: | January 2005 |
OBJECTIVES:
Primary
(phase I)
Secondary
OUTLINE: This is a phase I, dose-escalation study followed by an open-label, phase II study. Patients are assigned to a treatment according to Child-Pugh class of cirrhosis (class A/noncirrhotic vs class B).
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histological evidence of hepatocellular carcinoma (HCC)
Received 1 of the following therapies:
Meets 1 of the following high-risk features for recurrence:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 |
Study Chair: | Alan P. Venook, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000458055, UCSF-04459, UCSF-H43059-26066-02 |
Study First Received: | February 16, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00293436 History of Changes |
Health Authority: | United States: Federal Government |
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized resectable adult primary liver cancer |
Anti-Inflammatory Agents Erlotinib Liver Diseases Digestive System Neoplasms Celecoxib Carcinoma, Hepatocellular Cyclooxygenase Inhibitors Adjuvants, Immunologic Protein Kinase Inhibitors Carcinoma Liver Neoplasms |
Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Physiological Effects of Drugs Protein Kinase Inhibitors Liver Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Erlotinib Celecoxib |
Digestive System Neoplasms Neoplasms by Histologic Type Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Carcinoma Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Peripheral Nervous System Agents Antirheumatic Agents Adenocarcinoma Central Nervous System Agents Neoplasms, Glandular and Epithelial |