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Spots Global Cancer Trial Database for Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer

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Trial Identification

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

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Nancy Lee

Affiliation: Radiation Therapy Oncology Group

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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