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| Sponsor: | UNC Lineberger Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by (Responsible Party): | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01011010 |
Purpose
RATIONALE: Sorafenib tosylate 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. Drugs used in chemotherapy, such as doxorubicin hydrochloride and mitomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Chemoembolization kills tumor cells by carrying drugs directly into the tumor and blocking the blood flow to the tumor. Giving sorafenib tosylate together with chemoembolization may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects of sorafenib tosylate when given together with chemoembolization with doxorubicin hydrochloride and mitomycin in treating patients with liver cancer that cannot be removed by surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Cancer |
Drug: doxorubicin hydrochloride Drug: mitomycin C Drug: sorafenib tosylate Other: laboratory biomarker analysis Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase Ib Clinical Trial of Sorafenib in Combination With Transarterial Chemoembolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (HCC) |
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2009 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral sorafenib tosylate twice daily on days 1-14. Patients then undergo transarterial chemoembolization (TACE) comprising doxorubicin hydrochloride and mitomycin C on days 17-19*. Patients then receive oral sorafenib tosylate twice daily beginning after recovery from TACE and continuing in the absence of disease progression or unacceptable toxicity.
NOTE: *A second course of TACE may be administered within 8 weeks after the first TACE procedure.
Blood samples may be collected periodically for biomarker and pharmacokinetic analysis.
After completion of study treatment, patients are followed up at 3-4 weeks and then every 3 months for up to 3 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of hepatocellular carcinoma (HCC), as defined by 1 of the following:
Tissue histology
Measurable disease, according to modified HCC RECIST criteria
No complete thrombosis of the main portal vein
No evidence of extrahepatic/metastatic disease, such as lymph node metastases, lung or bone metastases, or peritoneal carcinomatosis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 12 weeks since prior major surgery or open biopsy
Contacts and Locations| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Wake Forest University Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Principal Investigator: | Bert H. O'Neil, MD | UNC Lineberger Comprehensive Cancer Center |
More Information
| Responsible Party: | UNC Lineberger Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01011010 History of Changes |
| Other Study ID Numbers: | LCCC 0902, P30CA016086, CDR0000648296 |
| Study First Received: | November 10, 2009 |
| Last Updated: | October 10, 2011 |
| Health Authority: | United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices |
|
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer recurrent adult primary liver cancer |
|
Liver Neoplasms Carcinoma, Hepatocellular Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Mitomycins |
Mitomycin Doxorubicin Sorafenib Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Alkylating Agents Protein Kinase Inhibitors |