Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 Clinical Trial
Official title:
A Phase II Study of Concurrent Chemoradiotherapy Using Three-Dimensional Conformal Radiotherapy (3D-CRT) or Intensity-Modulated Radiation Therapy (IMRT) + Bevacizumab (BV) for Locally or Regionally Advanced Nasopharyngeal Cancer
This phase II trial is studying how well giving bevacizumab together with cisplatin, radiation therapy, and fluorouracil works in treating patients with stage IIB, stage III, stage IVA, or stage IVB nasopharyngeal cancer. 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 nasopharyngeal cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cisplatin and fluorouracil, 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 chemotherapy and radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES:
I. Determine the safety and tolerability of bevacizumab and chemoradiotherapy comprising
cisplatin and radiotherapy followed by adjuvant therapy comprising cisplatin, fluorouracil,
and bevacizumab in patients with stage IIB-IVB nasopharyngeal cancer.
SECONDARY OBJECTIVES:
I. Determine the 1- and 2-year rates of locoregional progression-free in patients treated
with this regimen.
II. Determine the 1- and 2-year rates of distant metastases-free in patients treated with
this regimen.
III. Determine the 1- and 2-year rates of progression-free and overall survival of patients
treated with this regimen.
OUTLINE: This is a multicenter study.
BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and
cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in
the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients
also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy
once daily 5 days a week for a total of 33 fractions.
ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96
hours on days 1-4, cisplatin IV over 20-30 minutes on day 1 OR days 1 and 2, and bevacizumab
IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence
of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
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