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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077441 |
RATIONALE: Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well bortezomib works in treating patients with hepatocellular carcinoma (liver cancer) that cannot be removed with surgery.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: bortezomib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of PS-341 in Patients With Hepatocellular Carcinoma |
Study Start Date: | April 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from study entry.
PROJECTED ACCRUAL: A total of 22-55 patients will be accrued for this study within 9-19 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Not amenable to surgical resection
Measurable disease
Indicator lesion(s) outside the area of prior treatment
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, District of Columbia | |
Howard University Cancer Center at Howard University Hospital | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 | |
Australia, New South Wales | |
Sydney Cancer Centre at Royal Prince Alfred Hospital | |
Sydney, New South Wales, Australia, 2050 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital - Perth | |
Perth, Western Australia, Australia, 6009 | |
Hong Kong | |
Prince of Wales Hospital | |
Shatin, New Territories, Hong Kong | |
Korea, Republic of | |
Yonsei Cancer Center at Yonsei University Medical Center | |
Seoul, Korea, Republic of, 120-752 |
Study Chair: | George P. Kim, MD | Mayo Clinic |
Study ID Numbers: | CDR0000350328, MAYO-MC0255, NCI-6139 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077441 History of Changes |
Health Authority: | United States: Federal Government |
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Bortezomib Recurrence Carcinoma Protease Inhibitors |
Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Hepatocellular Carcinoma Neoplasms, Glandular and Epithelial |
Liver Diseases Neoplasms by Histologic Type Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Carcinoma, Hepatocellular Antineoplastic Agents Bortezomib Enzyme Inhibitors Pharmacologic Actions |
Protease Inhibitors Carcinoma Liver Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Adenocarcinoma Neoplasms, Glandular and Epithelial |