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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: | NCT00083226 |
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Bortezomib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving doxorubicin together with bortezomib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with bortezomib works in treating patients with liver cancer.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer |
Drug: bortezomib Drug: doxorubicin hydrochloride |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Bortezomib Plus Doxorubicin in Hepatocellular Carcinoma |
Estimated Enrollment: | 40 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 13 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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, Georgia | |
Veterans Affairs Medical Center - Atlanta (Decatur) | |
Decatur, Georgia, United States, 30033 | |
Winship Cancer Institute of Emory University | |
Altanta, Georgia, United States, 30322 | |
United States, Iowa | |
Mercy Medical Center - Sioux City | |
Sioux City, Iowa, United States, 51104 | |
Siouxland Hematology-Oncology Associates, LLP | |
Sioux City, Iowa, United States, 51101 | |
St. Luke's Regional Medical Center | |
Sioux City, Iowa, United States, 51104 | |
United States, Ohio | |
St. Rita's Medical Center | |
Lima, Ohio, United States, 45801 | |
United States, Pennsylvania | |
Albert Einstein Cancer Center | |
Philadelphia, Pennsylvania, United States, 19141 | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | |
Nashville, Tennessee, United States, 37232-6838 |
Study Chair: | Jordan D. Berlin, MD | Vanderbilt-Ingram Cancer Center |
Investigator: | William C. Chapman, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000363801, ECOG-E6202 |
Study First Received: | May 14, 2004 |
Last Updated: | October 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00083226 |
Health Authority: | United States: Food and Drug Administration |
adult primary hepatocellular carcinoma advanced adult primary liver cancer recurrent adult primary liver cancer localized unresectable adult primary liver cancer |
Liver Diseases Digestive System Neoplasms Carcinoma, Hepatocellular Bortezomib Liver neoplasms Recurrence Doxorubicin |
Carcinoma Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antibiotics, Antineoplastic Pharmacologic Actions Protease Inhibitors |