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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park, California, United States
Mercy San Juan Medical Center
Carmichael, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Start Date
December 13, 2006
Primary Completion Date
December 15, 2011
Completion Date
December 15, 2011
Last Updated
January 30, 2018
46
ACTUAL participants
3-Dimensional Conformal Radiation Therapy
RADIATION
Bevacizumab
BIOLOGICAL
Cisplatin
DRUG
Fluorouracil
DRUG
Intensity-Modulated Radiation Therapy
RADIATION
Lead Sponsor
National Cancer Institute (NCI)
Collaborators
Data Source & Attribution
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