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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00356889 |
RATIONALE: 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. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and erlotinib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving bevacizumab together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib works in treating patients with metastatic or unresectable biliary tumors.
Condition | Intervention | Phase |
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Extrahepatic Bile Duct Cancer Gallbladder Cancer |
Drug: bevacizumab Drug: erlotinib hydrochloride Procedure: immunohistochemistry staining method Procedure: laboratory biomarker analysis Procedure: molecular diagnostic method Procedure: mutation analysis Procedure: protein expression analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Bevacizumab and Erlotinib in Patients With Advanced Biliary Tumors |
Estimated Enrollment: | 55 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This an open-label, multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
After completion of study therapy, patients are followed periodically for up to 3 years.
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 or cytologically confirmed cholangiocarcinoma or gallbladder carcinoma
Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm with conventional techniques or as > 1.0 cm with spiral CT scan
PATIENT CHARACTERISTICS:
No concurrent illness or medical condition, including any of the following:
No abnormalities of the cornea based on any of the following:
No clinically significant cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent full-dose anticoagulants (e.g., warfarin) allowed provided PT/INR is > 1.5 and both of the following criteria are met:
United States, District of Columbia | |
Howard University Cancer Center | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 |
Study Chair: | Kyle D. Holen, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000484566, MAYO-MC044G, NCI-7024 |
Study First Received: | July 26, 2006 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00356889 |
Health Authority: | United States: Federal Government |
cholangiocarcinoma of the extrahepatic bile duct cholangiocarcinoma of the gallbladder recurrent gallbladder cancer |
unresectable gallbladder cancer recurrent extrahepatic bile duct cancer unresectable extrahepatic bile duct cancer |
Erlotinib Gallbladder Diseases Bile duct cancer, extrahepatic Cholangiocarcinoma Biliary Tract Neoplasms Digestive System Neoplasms Bevacizumab Recurrence |
Gall bladder cancer Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Gastrointestinal Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Angiogenesis Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |