Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00410956 |
RATIONALE: Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy directly into the arteries around the tumor together with bevacizumab may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving floxuridine and dexamethasone as a hepatic arterial infusion together with bevacizumab works in treating patients with unresectable primary liver cancer.
Condition | Intervention | Phase |
---|---|---|
Liver Cancer |
Biological: bevacizumab Drug: dexamethasone Drug: floxuridine Genetic: protein expression analysis Other: flow cytometry Other: immunoenzyme technique Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis Procedure: dynamic contrast-enhanced magnetic resonance imaging |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase II Study of Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Intravenous Bevacizumab (A Monoclonal Antibody to Vascular Endothelial Growth Factor-A), in Patients With Unresectable Primary Hepatic Malignancy |
Estimated Enrollment: | 55 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is an open-label, nonrandomized study.
Patients undergo placement of the hepatic arterial infusion (HAI) pump and a cholecystectomy. Approximately 2 weeks later, patients receive floxuridine and dexamethasone by HAI continuously on days 1-14 and bevacizumab IV over 30-90 minutes on day 15 of course 1 and on days 1 and 15 of all subsequent courses. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients undergo dynamic contrast-enhanced MRI (DCE-MRI) on days 1 and 15 of course 1 and then every 8 weeks thereafter.
Tumor and nontumor tissue is collected at the time of the HAI pump placement. Tissue is examined for the expression of vascular endothelial growth factor (VEGF)-A, -B, -C, and -D, placenta growth factor (PlGF), and VEGF receptor (VEGFR)-1, -2, and -3 by immunohistochemistry. Peripheral blood is collected at baseline and on day 1 of each course. Plasma levels of VEGF-A, -B, -C, and -D are measured by immunoenzyme techniques. Blood is also examined by flow cytometry and immunological methods and by protein extraction and analysis of VEGF and VEGFR expression (by western blot). Immunohistochemical markers of hypoxia in tissue, including hypoxia-inducible factor (HIF-1α), carbonic anhydrase IX (CA IX), glucose transporters (Glut-1 and Glut-3), and Ki-67 are assessed.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 55 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:
Histologically confirmed hepatocellular carcinoma (HCC) or intrahepatic cholangiocarcinoma (ICC)
PATIENT CHARACTERISTICS:
Urine protein < 1+ by dipstick or urine analysis OR urine protein:creatinine ratio < 1.0
No concurrent disease or illness that would preclude study participation, including any of the following:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: William R. Jarnagin, MD 212-639-7601 jarnagiw@mskcc.org | |
New York Weill Cornell Cancer Center at Cornell University | Recruiting |
New York, New York, United States, 10021 | |
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center 212-746-1848 |
Principal Investigator: | William R. Jarnagin, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( William R. Jarnagin ) |
Study ID Numbers: | CDR0000521522, MSKCC-06114, GENENTECH-MSKCC-06114 |
Study First Received: | December 11, 2006 |
Last Updated: | April 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00410956 History of Changes |
Health Authority: | Unspecified |
adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary cholangiocellular carcinoma |
Antimetabolites Anti-Inflammatory Agents Dexamethasone Liver Diseases Carcinoma, Hepatocellular Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Bevacizumab Hormones Liver Neoplasms Antibodies, Monoclonal Mitogens Hepatocellular Carcinoma Dexamethasone acetate |
Immunoglobulins Cholangiocarcinoma Digestive System Neoplasms Antineoplastic Agents, Hormonal Floxuridine Endothelial Growth Factors Angiogenesis Inhibitors Glucocorticoids Recurrence Carcinoma Antibodies Digestive System Diseases Gastrointestinal Neoplasms Peripheral Nervous System Agents |
Antimetabolites Dexamethasone Anti-Inflammatory Agents Liver Diseases Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Bevacizumab Hormones Liver Neoplasms Neoplasms by Site Therapeutic Uses |
Growth Inhibitors Angiogenesis Modulating Agents Dexamethasone acetate Digestive System Neoplasms Antineoplastic Agents, Hormonal Floxuridine Growth Substances Gastrointestinal Agents Angiogenesis Inhibitors Glucocorticoids Pharmacologic Actions Neoplasms Digestive System Diseases Autonomic Agents Peripheral Nervous System Agents |