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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00423930 |
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 head and neck cancer by blocking blood flow to the tumor. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving cisplatin and bevacizumab together with intensity-modulated radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying the side effects and how well giving cisplatin and bevacizumab together with intensity-modulated radiation therapy works in treating patients with stage III or stage IV head and neck cancer.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: bevacizumab Drug: cisplatin Procedure: conventional surgery Procedure: intensity-modulated radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Radiotherapy (IMRT) + Cisplatin + Bevacizumab for Patients With Stage III/IV Head and Neck Cancers |
Estimated Enrollment: | 42 |
Study Start Date: | October 2006 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Between 3-4 months after completion of chemoradiotherapy, patients undergo evaluation. Patients with clinical evidence of residual, progressive, or persistent disease may be eligible to undergo neck surgery at the discretion of their physician.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 42 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
PATIENT CHARACTERISTICS:
No arterial thromboembolic events within the past 3 years, including any of the following:
No other active malignancy except indolent malignancies that are unlikely to interfere with treatment or efficacy analysis, including any of the following:
No gross hemoptysis or hematemesis, defined as ≥ 1 teaspoon of bright red blood, within the past 28 days
No skin breakdown or ulceration
PRIOR CONCURRENT THERAPY:
No concurrent administration of any of the following:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10021 | |
Contact: David G. Pfister, MD 212-639-8235 |
Study Chair: | David G. Pfister, MD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Matthew G. Fury, MD, PhD | Memorial Sloan-Kettering Cancer Center |
Investigator: | Nancy Lee, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( David G. Pfister ) |
Study ID Numbers: | CDR0000518599, MSKCC-06130, PFIZER-MSKCC-06130 |
Study First Received: | January 16, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00423930 |
Health Authority: | Unspecified |
stage II squamous cell carcinoma of the hypopharynx 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 oropharynx stage IV squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity |
Epidermoid carcinoma Cisplatin 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 Radiation-Sensitizing Agents Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |