Bevacizumab, Cisplatin, Radiation Therapy, and Fluorouracil in Treating Patients With Stage IIB, Stage III, Stage IVA, or Stage IVB Nasopharyngeal Cancer
NCT ID: NCT00408694
Last Updated: 2018-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2006-12-13
2011-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (bevacizumab, cisplatin, fluorouracil, IMRT, 3D-CRT)
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.
3-Dimensional Conformal Radiation Therapy
Undergo 3D-CRT
Bevacizumab
Given IV
Cisplatin
Given IV
Fluorouracil
Given IV
Intensity-Modulated Radiation Therapy
Undergo IMRT
Interventions
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3-Dimensional Conformal Radiation Therapy
Undergo 3D-CRT
Bevacizumab
Given IV
Cisplatin
Given IV
Fluorouracil
Given IV
Intensity-Modulated Radiation Therapy
Undergo IMRT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologic WHO types I-IIb/III
* Stage IIB-IVB disease
* No T1-2, N1 disease in which node positivity is based on the presence of retropharyngeal lymph nodes
* No distant metastases
* Zubrod performance status 0-1
* WBC ? 4,000/mm?
* Hemoglobin ? 9.0 g/dL
* Platelet count ? 100,000/mm?
* Absolute neutrophil count ? 1,500/mm?
* INR ? 1.5
* aPTT ? 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ? 1.5 times ULN
* ALT and AST ? 1.5 times ULN
* Bilirubin ? 1.5 times ULN
* Creatinine ? 1.5 mg/dL OR creatinine clearance ? 55 mL/min
* Urine protein:creatinine (UPC) ratio \< 1.0
* If UPC \> 0.5, 24-hour urine protein must be \< 1,000 mg
* Hearing loss primarily sensorineural in nature and requiring a hearing aid or intervention that interferes in a clinically significant way with activities of daily living allowed
* Conductive hearing loss from tumor-related otitis media is allowed
* No severe, active comorbidity, including any of the following:
* Ongoing bleeding diathesis, hemorrhagic disorder, or coagulopathy within the past 6 months
* Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
* Esophageal varices, nonhealing wound, nonhealing ulcer, or bone fracture within the past 6 months
* Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within the past 30 days
* Unstable angina and/or congestive heart failure or peripheral vascular disease requiring hospitalization within the past 12 months
* Major medical or psychiatric illness that, in the opinion of the study investigator, would preclude study compliance
* Active, untreated infection and/or acute bacterial or fungal infection requiring intravenous antibiotics
* Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects
* History of significant weight loss (\> 15% from baseline)
* History of arterial thromboembolic events
* Acquired immune deficiency syndrome
* Transmural myocardial infarction
* Cerebrovascular accident
* Transient ischemic attack
* Any other cardiac condition that, in the opinion of the investigator, would preclude study compliance
* No gross hemoptysis or hematemesis, defined as bright red blood of ? 1 teaspoon per coughing episode, within the last 4 weeks (incidental blood mixed with phlegm allowed)
* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the breast, oral cavity, or cervix
* Nutritional and physical condition considered suitable for study treatment
* No significant traumatic injury within the past 4 weeks
* No history of allergic reaction to the study drugs
* No baseline blood pressure \> 150/100 mm Hg
* No peripheral neuropathy ? grade 2
* Not pregnant or nursing
* Negative serum pregnancy test
* Fertile patients must use effective contraception during and for ? 6 months after completion of study treatment
* At least 10 days since prior and no concurrent dipyridamole, ticlopidine, clopidogrel bisulfate, cilostazol, warfarin, heparin, daily treatment with acetylsalicylic acid (\> 325 mg/day), or nonsteroidal anti-inflammatory medications known to inhibit platelet function
* No prior head and neck surgery of the primary tumor or lymph nodes except for incisional or excisional biopsies
* More than 15 days since prior biopsies
* More than 1 week since prior fine-needle aspirations or placement of percutaneous gastrostomy tube
* More than 4 weeks since prior major surgical procedures
* No prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
* No prior bevacizumab or other vascular endothelial growth factor-targeting agents
* No prior systemic chemotherapy for the study cancer
* Prior chemotherapy for a different cancer allowed
* No concurrent hematologic growth factors (e.g. filgrastim \[G-CSF\], darbepoetin alfa, epoetin alfa) during study chemoradiotherapy
* No concurrent prophylactic growth factors for neutropenia during study adjuvant therapy
* No concurrent prophylactic amifostine or pilocarpine
* No other concurrent experimental therapeutic cancer treatments
18 Years
ALL
No
Sponsors
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Radiation Therapy Oncology Group
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Nancy Lee
Role: PRINCIPAL_INVESTIGATOR
Radiation Therapy Oncology Group
Locations
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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
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
Integrated Community Oncology Network-Florida Cancer Center Beaches
Jacksonville Beach, 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
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Children's Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, 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 Township, 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
Countries
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References
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Lee NY, Harris J, Kim J, Garden A, Mechalakos J, Pfister DG, Chan ATC, Hu K, Colevas AD, Frank S, Shenouda G, Bar-Ad V, Waldron JN, Harari PM, Raben A, Torres-Saavedra P, Le QT. Long-term Outcomes of Bevacizumab and Chemoradiation for Locoregionally Advanced Nasopharyngeal Carcinoma: A Nonrandomized Controlled Trial. JAMA Netw Open. 2023 Jun 1;6(6):e2316094. doi: 10.1001/jamanetworkopen.2023.16094.
Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.
Other Identifiers
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NCI-2009-00736
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG-0615
Identifier Type: -
Identifier Source: secondary_id
CDR0000518526
Identifier Type: -
Identifier Source: secondary_id
RTOG 0615
Identifier Type: OTHER
Identifier Source: secondary_id
RTOG-0615
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00736
Identifier Type: -
Identifier Source: org_study_id
NCT00707096
Identifier Type: -
Identifier Source: nct_alias
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