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| Sponsor: | University of Chicago |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00023959 |
Purpose
RATIONALE: 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. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with chemotherapy and radiation therapy may be an effective treatment for head and neck cancer.
PURPOSE: This phase I trial is to see if combining bevacizumab, fluorouracil, and hydroxyurea with radiation therapy works in treating patients who have advanced head and neck cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Biological: bevacizumab Biological: filgrastim Drug: fluorouracil Drug: hydroxyurea Radiation: radiation therapy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase I Study Of Bevacizumab (Recombinant Humanized Monoclonal Antibody To Vascular Endothelial Growth Factor) In Addition To Flourouracil And Hydroxyurea As Initial Chemotherapy With Concomitant Radiotherapy (B-FHX) For Poor Prognosis Head And Neck Cancer |
| Study Start Date: | October 2001 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of bevacizumab.
Patients receive oral hydroxyurea every 12 hours on days 1-6, fluorouracil IV continuously on days 1-5, and bevacizumab IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 7 courses in the absence of disease progression or unacceptable toxicity.
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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Additional patients are treated at the MTD.
PROJECTED ACCRUAL: A total of 27-39 patients will be accrued for this study within 5.4-19.5 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 advanced head and neck cancer
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:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Evanston Northwestern Health Care - Evanston Hospital | |
| Evanston, Illinois, United States, 60201-1781 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| Study Chair: | Everett E. Vokes, MD | University of Chicago |
More Information
| ClinicalTrials.gov Identifier: | NCT00023959 History of Changes |
| Other Study ID Numbers: | CDR0000068879, UCCRC-11033, NCI-2630 |
| Study First Received: | September 13, 2001 |
| Last Updated: | May 7, 2010 |
| Health Authority: | United States: Federal Government |
|
untreated metastatic squamous neck cancer with occult primary recurrent metastatic squamous neck cancer with occult primary metastatic squamous neck cancer with occult primary squamous cell carcinoma stage III squamous cell carcinoma of the lip and oral cavity stage III basal cell carcinoma of the lip stage III verrucous carcinoma of the oral cavity stage III mucoepidermoid carcinoma of the oral cavity stage III adenoid cystic carcinoma of the oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage IV basal cell carcinoma of the lip stage IV verrucous carcinoma of the oral cavity stage IV mucoepidermoid carcinoma of the oral cavity stage IV adenoid cystic carcinoma of the oral cavity recurrent squamous cell carcinoma of the lip and oral cavity recurrent basal cell carcinoma of the lip |
recurrent verrucous carcinoma of the oral cavity recurrent mucoepidermoid carcinoma of the oral cavity recurrent adenoid cystic carcinoma of the oral cavity stage III squamous cell carcinoma of the oropharynx stage III lymphoepithelioma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage IV lymphoepithelioma of the oropharynx recurrent squamous cell carcinoma of the oropharynx recurrent lymphoepithelioma of the oropharynx stage III squamous cell carcinoma of the nasopharynx stage III lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx recurrent squamous cell carcinoma of the nasopharynx recurrent lymphoepithelioma of the nasopharynx |
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Fluorouracil Bevacizumab Hydroxyurea Lenograstim Endothelial Growth Factors Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents |
Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antisickling Agents Hematologic Agents Enzyme Inhibitors Nucleic Acid Synthesis Inhibitors Growth Substances Adjuvants, Immunologic Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Inhibitors |