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Brief Title: Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer
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
Study ID: NCT00408694
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
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
Valley Medical Oncology Consultants-Fremont, Fremont, California, United States
Contra Costa Regional Medical Center, Martinez, California, United States
Highland General Hospital, Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States
Bay Area Tumor Institute, Oakland, California, United States
Hematology and Oncology Associates-Oakland, Oakland, California, United States
Tom K Lee Inc, Oakland, California, United States
Stanford Cancer Institute Palo Alto, Palo Alto, California, United States
Valley Care Health System - Pleasanton, Pleasanton, California, United States
Valley Medical Oncology Consultants, Pleasanton, California, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville, Roseville, California, United States
Sutter Medical Center Sacramento, Sacramento, California, United States
Mercy General Hospital Radiation Oncology Center, Sacramento, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center, San Pablo, California, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville, Vacaville, California, United States
Beebe Medical Center, Lewes, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Boca Raton Regional Hospital, Boca Raton, Florida, United States
Integrated Community Oncology Network-Florida Cancer Center Beaches, Jacksonville Beach, Florida, United States
Baptist MD Anderson Cancer Center, Jacksonville, Florida, United States
Integrated Community Oncology Network-Southside Cancer Center, Jacksonville, Florida, United States
Baptist Medical Center South, Jacksonville, Florida, United States
Baptist Hospital of Miami, Miami, Florida, United States
21st Century Oncology-Orange Park, Orange Park, Florida, United States
UF Cancer Center at Orlando Health, Orlando, Florida, United States
21st Century Oncology-Palatka, Palatka, Florida, United States
Integrated Community Oncology Network-Flager Cancer Center, Saint Augustine, Florida, United States
Memorial University Medical Center, Savannah, Georgia, United States
John H Stroger Jr Hospital of Cook County, Chicago, Illinois, United States
Saint Vincent Anderson Regional Hospital/Cancer Center, Anderson, Indiana, United States
Union Hospital of Cecil County, Elkton, Maryland, United States
Bronson Battle Creek, Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital, Big Rapids, Michigan, United States
Cancer Research Consortium of West Michigan NCORP, Grand Rapids, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Holland Community Hospital, Holland, Michigan, United States
Borgess Medical Center, Kalamazoo, Michigan, United States
Bronson Methodist Hospital, Kalamazoo, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Mercy Health Partners-Hackley Campus, Muskegon, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
Metro Health Hospital, Wyoming, Michigan, United States
Singing River Hospital, Pascagoula, Mississippi, United States
Saint Louis Children's Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CoxHealth South Hospital, Springfield, Missouri, United States
University Medical Center of Southern Nevada, Las Vegas, Nevada, United States
Cooper Hospital University Medical Center, Camden, New Jersey, United States
Virtua Memorial, Mount Holly, New Jersey, United States
Saint Peter's University Hospital, New Brunswick, New Jersey, United States
Rutgers New Jersey Medical School, Newark, New Jersey, United States
Community Medical Center, Toms River, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Beth Israel Medical Center, New York, New York, United States
Saint Luke's Roosevelt Hospital Center - Saint Luke's Division, New York, New York, United States
Rutherford Hospital, Rutherfordton, North Carolina, United States
Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
UPMC-Heritage Valley Health System Beaver, Beaver, Pennsylvania, United States
UPMC Cancer Center at Clarion Hospital, Clarion, Pennsylvania, United States
Northeast Radiation Oncology Center, Dunmore, Pennsylvania, United States
Pocono Medical Center, East Stroudsburg, Pennsylvania, United States
UPMC Cancer Centers - Arnold Palmer Pavilion, Greensburg, Pennsylvania, United States
UPMC-Johnstown/John P. Murtha Regional Cancer Center, Johnstown, Pennsylvania, United States
UPMC Cancer Center at UPMC McKeesport, McKeesport, Pennsylvania, United States
Upper Delaware Valley Cancer Center, Milford, Pennsylvania, United States
UPMC-Coraopolis/Heritage Valley Radiation Oncology, Moon, Pennsylvania, United States
UPMC Cancer Center-Natrona Heights, Natrona Heights, Pennsylvania, United States
UPMC Jameson, New Castle, Pennsylvania, United States
Radiation Therapy Oncology Group, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
UPMC-Magee Womens Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Presbyterian Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Saint Margaret, Pittsburgh, Pennsylvania, United States
UPMC-Shadyside Hospital, Pittsburgh, Pennsylvania, United States
UPMC Jefferson Regional Radiation Oncology, Pittsburgh, Pennsylvania, United States
UPMC-Passavant Hospital, Pittsburgh, Pennsylvania, United States
UPMC-Saint Clair Hospital Cancer Center, Pittsburgh, Pennsylvania, United States
UPMC Cancer Center at UPMC Northwest, Seneca, Pennsylvania, United States
UPMC Uniontown Hospital Radiation Oncology, Uniontown, Pennsylvania, United States
UPMC Washington Hospital Radiation Oncology, Washington, Pennsylvania, United States
AnMed Health Hospital, Anderson, South Carolina, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
Brooke Army Medical Center, Fort Sam Houston, Texas, United States
M D Anderson Cancer Center, Houston, Texas, United States
Wilford Hall Medical Center, Lackland Air Force Base, Texas, United States
Wheeling Hospital/Schiffler Cancer Center, Wheeling, West Virginia, United States
Froedtert and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Aspirus UW Cancer Center, Wisconsin Rapids, Wisconsin, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
London Regional Cancer Program, London, Ontario, Canada
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
Name: Nancy Lee
Affiliation: Radiation Therapy Oncology Group
Role: PRINCIPAL_INVESTIGATOR