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Sponsors and Collaborators: |
Duke University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00276575 |
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 and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and everolimus may also block blood flow to the tumor. Giving everolimus and erlotinib together with bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase I trial is studying the side effects and best dose of erlotinib and everolimus when given together with bevacizumab in treating patients with advanced solid tumors.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Biological: bevacizumab Drug: erlotinib hydrochloride Drug: everolimus |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | Phase I Study of Bevacizumab in Combination With Everolimus and Erlotinib in Advanced Cancer |
Estimated Enrollment: | 40 |
Study Start Date: | March 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study followed by a randomized study.
NOTE: *The first cohort of patients receive bevacizumab and everolimus only until the MTD is determined, the subsequent cohorts of patients receive bevacizumab, everolimus, and erlotinib hydrochloride
Part 2: Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 40 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 malignancy
PATIENT CHARACTERISTICS:
No New York Heart Association class II-IV congestive heart failure
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic anticoagulation
No concurrent administration of any of the following drugs:
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Herbert I. Hurwitz, MD | Duke University |
Study ID Numbers: | CDR0000449970, DUMC-6026-05-6R1, GENENTECH-DUMC-6026-05-6R1, NOVARTIS-DUMC-6026-05-6R1 |
Study First Received: | January 12, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00276575 History of Changes |
Health Authority: | United States: Food and Drug Administration |
unspecified adult solid tumor, protocol specific |
Everolimus Erlotinib Immunologic Factors Bevacizumab |
Protein Kinase Inhibitors Angiogenesis Inhibitors Immunosuppressive Agents |
Everolimus Erlotinib Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors |
Bevacizumab Protein Kinase Inhibitors Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |