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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00767468 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of sorafenib in treating patients with locally advanced or metastatic liver cancer and cirrhosis.
Condition | Intervention | Phase |
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Liver Cancer |
Drug: Tc 99m sestamibi Drug: sorafenib tosylate Drug: technetium Tc 99m mebrofenin Procedure: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase IB Study of Sorafenib for Patient With Locally Advanced or Metastatic Hepatocellular Carcinoma and Child's B Cirrhosis |
Estimated Enrollment: | 30 |
Study Start Date: | October 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to degree of hepatic dysfunction (moderate [bilirubin ≤ 3 times upper limit of normal (ULN)] vs severe [bilirubin > 3 times but ≤ 6 times ULN]).
Patients receive oral sorafenib tosylate twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo hepatic scintigraphy with technetium Tc 99m mebrofinin (MEB) and technetium Tc 99m sestamibi (MIBI) at baseline. Blood and urine samples are collected periodically for pharmacokinetic studies.
After completion of study therapy, patients are followed at 3-4 weeks and then every 3 months thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Child-Pugh class B cirrhosis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No more than one prior therapy including, but not limited to, any of the following:
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 |
Principal Investigator: | Bert H. O'Neil, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000615311, UNC-LCCC-0717, BAYER-UNC-LCCC-0717 |
Study First Received: | October 4, 2008 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00767468 |
Health Authority: | United States: Food and Drug Administration |
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 Fibrosis Liver neoplasms Liver Cirrhosis Recurrence Carcinoma |
Liver Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Sorafenib Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Neoplasms Pathologic Processes Neoplasms by Site Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |