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
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, 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Grade 4 Hemorrhage or Any Grade 5 Adverse Event Assessed to be Definitely, Probably, or Possibly Related to Protocol Treatment During the First Year.
Estimated using a binomial distribution along with their associated 95% confidence intervals. Graded using the CTCAE version 3.0.
From start of treatment to one year.
Yes
Nancy Lee
Principal Investigator
American College of Radiology Imaging Network
United States: Food and Drug Administration
NCI-2009-00736
NCT00408694
December 2006
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Stanford University | Stanford, California 94305 |
Community Medical Center | Toms River, New Jersey 08755 |
Beth Israel Medical Center | New York, New York 10003 |
Brooke Army Medical Center | Fort Sam Houston, Texas 78234-6200 |
Wilford Hall Medical Center | Lackland Air Force Base, Texas 78236-5300 |
Holland Community Hospital | Holland, Michigan 49423 |
Munson Medical Center | Traverse City, Michigan 49684 |
City of Hope Medical Center | Duarte, California 91010 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
Beebe Medical Center | Lewes, Delaware 19958 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Highland General Hospital | Oakland, California 94602 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Metro Health Hospital | Grand Rapids, Michigan 49506 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
East Bay Radiation Oncology Center | Castro Valley, California 94546 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Larry G Strieff MD Medical Corporation | Oakland, California 94609 |
University of Pittsburgh Medical Center - Shadyside Hospital | Pittsburgh, Pennsylvania 15213-2582 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
UPMC Cancer Center at Jefferson Regional Medical Center | Clairton, Pennsylvania 15025 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
M D Anderson Cancer Center | Houston, Texas 77030 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Valley Medical Oncology Consultants-Castro Valley | Castro Valley, California 94546 |
Eden Hospital Medical Center | Castro Valley, California 94546 |
Valley Medical Oncology Consultants-Fremont | Fremont, California 94538 |
Bay Area Breast Surgeons Inc | Oakland, California 94609 |
Bay Area Tumor Institution CCOP | Oakland, California 94609 |
Tom K Lee Inc | Oakland, California 94609 |
Valley Medical Oncology Consultants | Pleasanton, California 94588 |
Valley Care Health System - Pleasanton | Pleasanton, California 94588 |
Doctors Medical Center- JC Robinson Regional Cancer Center | San Pablo, California 94806 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
John H Stroger Jr Hospital of Cook County | Chicago, Illinois 60612-3785 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Mercy Health Partners-Hackley Campus | Muskegon, Michigan 49442 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Saint Luke's Roosevelt Hospital Center - Saint Luke's Division | New York, New York 10025 |
Pocono Medical Center | East Stroudsburg, Pennsylvania 18301 |
Wheeling Hospital | Wheeling, West Virginia 26003 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
Radiological Associates of Sacramento | Sacramento, California 95816 |
UMDNJ - New Jersey Medical School | Newark, New Jersey 07103 |
Riverview Hospital | Wisconsin Rapids, Wisconsin 54494 |
Magee-Womens Hospital - University of Pittsburgh Medical Center | Pittsburgh, Pennsylvania 15213 |
Upper Delaware Valley Cancer Center | Milford, Pennsylvania 18337 |
UPMC Cancer Center at UPMC McKeesport | McKeesport, Pennsylvania 15132 |
Washington Hospital | Washington, Pennsylvania 15301 |
Boca Raton Regional Hospital | Boca Raton, Florida 33486 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Auburn Radiation Oncology Center | Auburn, California 95603 |
Marshall Radiation Oncology Center | Cameron Park, California 95682 |
Mercy San Juan Medical Center | Carmichael, California 95608 |
Roseville Radiation Oncology Center | Roseville, California 95661 |
Mercy General Hospital Radiation Oncology Center | Sacramento, California 95819 |
Saint Louis Children's Hospital | Saint Louis, Missouri 63110 |
UPMC - Heritage Valley Health System - The Medical Center - Beaver | Beaver, Pennsylvania 15009 |
UPMC Cancer Center at Clarion Hospital | Clarion, Pennsylvania 16214 |
UPMC Cancer Centers - Arnold Palmer Pavilion | Greensburg, Pennsylvania 15601 |
University Pittsburgh Medical Cancer Center-Johnstown | Johnstown, Pennsylvania 15901 |
University of Pittsburgh Medical Center -Moon Township | Moon Township, Pennsylvania 15108 |
University of Pittsburgh Medical Cancer Center - Natrona Heights | Natrona Heights, Pennsylvania 15065 |
Jameson Health System North Campus | New Castle, Pennsylvania 16105 |
University of Pittsburgh Medical Center-Passavant Hospital | Pittsburgh, Pennsylvania 15237 |
University of Pittsburgh Medical Center-Presbyterian Hospital | Pittsburgh, Pennsylvania 15213 |
UPMC Cancer Center at Saint Clair Hospital | Pittsburgh, Pennsylvania 15243 |
Saint Margaret Memorial Hospital | Pittsburgh, Pennsylvania 15215 |
University of Pittsburgh Medical Center Northwest | Seneca, Pennsylvania 16346 |
UPMC Cancer Center - Robert E Eberly Pavilion | Uniontown, Pennsylvania 15401 |