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| Sponsor: | Robert H. Lurie Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00057980 |
Purpose
RATIONALE: Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining celecoxib with epirubicin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of epirubicin when given together with celecoxib and to see how well it works in treating patients with hepatocellular carcinoma (liver cancer).
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: celecoxib Drug: epirubicin hydrochloride |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Study of Epirubicin and Celecoxib for Hepatocellular Carcinoma |
| Study Start Date: | October 2002 |
| Estimated Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of epirubicin.
Cohorts of 3-5 patients receive escalating doses of epirubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 3 of 5 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 3-52 patients (3-15 for phase I and 12-37 for phase II) will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of localized or metastatic hepatocellular carcinoma (HCC) by 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611 | |
| Study Chair: | Mary Mulcahy, MD | Robert H. Lurie Cancer Center |
More Information
| Study ID Numbers: | CDR0000285669, NU-02I6 |
| Study First Received: | April 7, 2003 |
| Last Updated: | January 24, 2009 |
| ClinicalTrials.gov Identifier: | NCT00057980 History of Changes |
| Health Authority: | United States: Federal Government |
|
advanced adult primary liver cancer localized unresectable adult primary liver cancer adult primary hepatocellular carcinoma |
|
Anti-Inflammatory Agents Liver Diseases Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Antineoplastic Agents Physiological Effects of Drugs Antibiotics, Antineoplastic Liver Neoplasms Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Celecoxib Digestive System Neoplasms |
Neoplasms by Histologic Type Cyclooxygenase Inhibitors Enzyme Inhibitors Epirubicin 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 |