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Sponsors and Collaborators: |
Ireland Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00054262 |
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 T900607 in treating patients who have unresectable liver cancer.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: T900607 |
Phase II |
Study Type: | Interventional |
Study Design: | Open Label, Treatment |
Official Title: | A Phase II Study Of Intravenous T900607-Sodium In Subjects With Chemotherapy-Naive Unresectable Hepatocellular Carcinoma |
Study Start Date: | November 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive T900607 IV over 1 hour once weekly. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 20-35 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:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
At least 6 weeks since prior surgical resection (an indicator lesion must exist outside the area of therapy)
Other
United States, Ohio | |
Ireland Cancer Center | |
Cleveland, Ohio, United States, 44106-1714 |
Study Chair: | Joanna M. Brell, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000270198, CWRU-100211, TULA-T-607-004, TULA-TULI-2202 |
Study First Received: | February 5, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00054262 History of Changes |
Health Authority: | United States: Federal Government |
adult primary hepatocellular carcinoma advanced adult primary liver cancer localized unresectable adult primary liver cancer |
Liver Neoplasms Liver Diseases Digestive System Diseases Digestive System Neoplasms Carcinoma, Hepatocellular |
Gastrointestinal Neoplasms Hepatocellular Carcinoma Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Liver Neoplasms Liver Diseases Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms |
Neoplasms by Histologic Type Carcinoma, Hepatocellular Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |