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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00052364 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating patients who have unresectable, recurrent or metastatic liver cancer.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: oxaliplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Oxaliplatin In Hepatocellular Cancer |
Study Start Date: | September 2002 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to presence of the fibrolamellar variant of hepatocellular cancer (yes vs no).
Patients receive oxaliplatin IV over 2 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 18-32 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:
Histologically confirmed hepatocellular cancer
Unidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study ID Numbers: | CDR0000258202, CCC-PHII-36, CHNMC-PHII-36, NCI-5589 |
Study First Received: | January 24, 2003 |
Last Updated: | February 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00052364 History of Changes |
Health Authority: | United States: Federal Government |
advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma |
Liver Neoplasms Oxaliplatin Liver Diseases Digestive System Diseases Digestive System Neoplasms |
Carcinoma, Hepatocellular Gastrointestinal Neoplasms Hepatocellular Carcinoma Recurrence Carcinoma |
Liver Neoplasms Oxaliplatin Liver Diseases Neoplasms Digestive System Diseases |
Neoplasms by Site Digestive System Neoplasms Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |