Head and Neck Cancer Clinical Trial
Official title:
A Phase II Study of Radiotherapy (IMRT) + Cisplatin + Bevacizumab for Patients With Stage III/IV Head and Neck Cancers
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.
OBJECTIVES:
Primary
- Determine the 2-year progression-free survival of patients with stage III or IV
squamous cell carcinoma of the head and neck treated with chemoradiotherapy comprising
cisplatin, bevacizumab, and intensity-modulated radiotherapy.
- Determine the safety and tolerability of this regimen in these patients.
Secondary
- Determine the median overall survival of patients treated with this regimen.
OUTLINE:
- Chemoradiotherapy: Patients receive cisplatin IV over 1 hour on days 1, 2, 22, 23, 43,
and 44 and bevacizumab IV over 30-90 minutes on days 1, 22, and 43. Patients also
undergo intensity-modulated radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40,
and 43-47. Treatment continues in the absence of disease progression or unacceptable
toxicity.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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