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Sponsors and Collaborators: |
Case Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00281840 |
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. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving bevacizumab together with docetaxel and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and radiation therapy works in treating patients with stage III or stage IV head and neck cancer.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: bevacizumab Drug: docetaxel Procedure: conventional surgery Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Bevacizumab in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck |
Estimated Enrollment: | 30 |
Study Start Date: | September 2005 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo radiotherapy once daily, 5 days a week, for 8 weeks and receive docetaxel IV over 1 hour once a week for 8 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year.
Approximately 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 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 squamous cell carcinoma of the head and neck
Stage III or IV disease
No known CNS or brain metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Ohio | |
Case Comprehensive Cancer Center | |
Cleveland, Ohio, United States, 44106-5065 | |
Geauga Regional Hospital | |
Chardonr, Ohio, United States, 44024 | |
Lake/University Ireland Cancer Center | |
Mentor, Ohio, United States, 44060 | |
Mercy Cancer Center at Mercy Medical Center | |
Canton, Ohio, United States, 44708 | |
MetroHealth Cancer Care Center at MetroHealth Medical Center | |
Cleveland, Ohio, United States | |
Southwest General Health Center | |
Middleburgh Heights, Ohio, United States, 44130 | |
UHHS Chagrin Highlands Medical Center | |
Orange Villager, Ohio, United States, 44122 | |
UHHS Westlake Medical Center | |
Westlaker, Ohio, United States, 44145 | |
University Suburban Health Center | |
South Euclid, Ohio, United States, 44121 | |
United States, Pennsylvania | |
UPMC Cancer Centers | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Chair: | Panos Savvides, MD | Case Comprehensive Cancer Center |
Study ID Numbers: | CDR0000450900, CASE-6304, CASE-030550 |
Study First Received: | January 24, 2006 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00281840 |
Health Authority: | United States: Federal Government |
stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity |
stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx |
Docetaxel Epidermoid carcinoma Nasopharyngeal carcinoma Squamous cell carcinoma Head and Neck Neoplasms Carcinoma, squamous cell |
Laryngeal carcinoma Hypopharyngeal cancer Bevacizumab Carcinoma, Squamous Cell Dental Caries Carcinoma |
Neoplasms Neoplasms by Site Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |