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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00055913 |
Purpose
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes needed for tumor cell growth. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining erlotinib with bevacizumab may kill more tumor cells.
PURPOSE: This randomized phase I/II trial is to see if combining erlotinib with bevacizumab works better in treating patients who have recurrent or metastatic head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Biological: bevacizumab Drug: erlotinib hydrochloride |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase I/II Study Of Bevacizumab (rhuMAb VEGF) In Combination With OSI-774 For Patients With Recurrent Or Metastatic Cancer Of The Head And Neck |
| Study Start Date: | May 2003 |
| Estimated Primary Completion Date: | May 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive bevacizumab IV over 30-90 minutes on day 15 and oral erlotinib on days 1-28.
|
Biological: bevacizumab
Given IV
Drug: erlotinib hydrochloride
Given orally
|
|
Arm II: Experimental
Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral erlotinib on days 1-28.
|
Biological: bevacizumab
Given IV
Drug: erlotinib hydrochloride
Given orally
|
OBJECTIVES:
OUTLINE: This is a dose-escalation study of bevacizumab followed by a randomized, multicenter study.
Cohorts of 3-6 patients receive escalating doses of bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Phase II: Course 1 is 28 days in length. All subsequent courses are 21 days.
Course 1: Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for the phase I portion of this study within 2-9 months and 40 patients for the phase II portion of this study within 8-20 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed squamous cell cancer of the head and neck
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
No arterial thromboembolic event within the past 6 months, including any of the following:
Ophthalmologic
No significant ophthalmologic abnormalities* including any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Illinois | |
| Cardinal Bernardin Cancer Center at Loyola University Medical Center | |
| Maywood, Illinois, United States, 60153 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Ingalls Cancer Care Center at Ingalls Memorial Hospital | |
| Harvey, Illinois, United States, 60426 | |
| La Grange Memorial Hospital | |
| La Grange, Illinois, United States, 60525 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Oncology/Hematology Associates of Central Illinois, P.C. | |
| Peoria, Illinois, United States, 61615-7828 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| University of Illinois Medical Center | |
| Chicago, Illinois, United States, 60612-7317 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| United States, Michigan | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: | Ezra Cohen, MD | University of Chicago |
More Information
| Study ID Numbers: | CDR0000271444, UCCRC-11956A, NCI-5701, UCCRC-NCI-5701 |
| Study First Received: | March 6, 2003 |
| Last Updated: | March 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00055913 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent squamous cell carcinoma of the hypopharynx |
recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity salivary gland squamous cell carcinoma |
|
Erlotinib Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Enzyme Inhibitors Bevacizumab Protein Kinase Inhibitors |
Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Head and Neck Neoplasms Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors |