Afatinib After Chemoradiation and Surgery in Treating Patients With Stage III-IV Squamous Cell Carcinoma of the Head and Neck at High-Risk of Recurrence
NCT ID: NCT01824823
Last Updated: 2023-06-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2014-06-30
2020-12-31
Brief Summary
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Detailed Description
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I. Examine disease-free survival (DFS) given afatinib/placebo adjuvant therapy in patients with viable tumors in lymph nodes after neck dissection for suspected residual disease after concurrent chemoradiation.
SECONDARY OBJECTIVES:
I. Evaluate the recurrence rate, recurrence patterns, development of second primary malignancies, overall survival (OS) and toxicity of afatinib/placebo.
II. Evaluate on-target inhibition by afatinib, and determine circulating deoxyribonucleic acid (DNA) as a biomarker of afatinib resistance.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive afatinib orally (PO) once daily (QD) on days 1-28.
ARM B: Patients receive placebo PO QD on days 1-28.
In both Arms, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year and then every 12 months for 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm A (afatinib)
Patients receive afatinib PO QD on days 1-28.
afatinib
Given PO
Arm B (placebo)
Patients receive placebo PO QD on days 1-28.
placebo
Given PO
Interventions
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afatinib
Given PO
placebo
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have pathological evidence of persistent primary and/or lymph node disease with viable tumor cells following primary concurrent chemoradiotherapy of locoregionally advanced (stage III/IV) HNSCC of the oral cavity, oropharynx, larynx, hypopharynx or p16-positive unknown primary of the head and neck region; persistent primary and/or lymph node disease with viable tumor cells will be determined by the histological determination of tumor viability defined as tumor cells with intact cellular compartments (i.e. cytoplasm and nucleus) that do not exhibit karyolysis, pyknosis, or karyorrhexis on haematoxylin and eosin (H\&E) staining
* Patients must have undergone a neck dissection following completion of chemoradiotherapy and must have involved at the minimum a compartment dissection of nodal levels with residual abnormalities on post-treatment imaging studies and/or received a complete resection of the residual primary lesion with negative margins
* Patients must have achieved a complete response at the primary disease site after chemoradiotherapy or complete resection of the residual primary site disease with negative margins
* All persistent lymph node disease must have received at least 66 Gy of radiotherapy and must have been completely surgically resected prior to registration, and surgical incisions should be adequately healed
* Patients with extracapsular lymph node extension, perineural or lymphovascular invasion will be eligible
* Patients must be at least 6 weeks (42 days) and no more than 36 weeks (252 days) from completion of chemoradiation at the time of registration
* Patients will be eligible regardless of ability to swallow; patients with dysphagia may have afatinib/placebo administered via gastrostomy tube
* Absolute neutrophil count \>= 1,000/mm\^3
* Platelets \>= 100,000/mm\^3
* Total bilirubin =\< 1.5 x the upper limit of normal (ULN)
* Aspartate amino transferase (AST) =\< 3 x the ULN
* Alanine amino transferase (ALT) =\< 3 x the ULN
* Calculated creatinine clearance must be \>= 50 ml/min using the Cockcroft-Gault formula
* Prior cetuximab or any epidermal growth factor receptor (EGFR) inhibitors will not be permitted including cetuximab administered with a chemoradiotherapy or radiotherapy regimen
* As all patients in this study will have received prior full dose, curative-intent external-beam radiotherapy to the involved neck, no additional external-beam radiotherapy will be permitted prior to or during study participation
* Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
* Patients must have electrocardiogram (ECG) within 8 weeks prior to randomization to the study
* Patients must be assessed for cardiac function by echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) within 8 weeks prior to randomization
Exclusion Criteria
* Known hypersensitivity to afatinib or any of the excipients of this product
* Prior adjuvant chemotherapy (aside from the initial induction chemotherapy followed by chemoradiotherapy or chemoradiotherapy regimen)
* History of acute myocardial infarction within 3 months prior to registration, and any history of uncontrolled angina, uncontrolled arrhythmia, or uncontrolled heart failure
* Pregnant or breast-feeding women
* Active infections, other cancers, or history of other cancers
* Participation in any other clinical trials or taking any other experimental medications
* Left ventricular dysfunction
* Evidence of interstitial lung disease
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
ECOG-ACRIN Cancer Research Group
NETWORK
Responsible Party
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Principal Investigators
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Christine Chung
Role: PRINCIPAL_INVESTIGATOR
Eastern Cooperative Oncology Group
Locations
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Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States
Alaska Women's Cancer Care
Anchorage, Alaska, United States
Anchorage Oncology Centre
Anchorage, Alaska, United States
Katmai Oncology Group
Anchorage, Alaska, United States
Providence Alaska Medical Center
Anchorage, Alaska, United States
Veteran's Administration Medical Center
Little Rock, Arkansas, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States
Beebe Medical Center
Lewes, Delaware, United States
Christiana Gynecologic Oncology LLC
Newark, Delaware, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Regional Hematology and Oncology PA
Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Nanticoke Memorial Hospital
Seaford, Delaware, United States
Christiana Care Health System-Wilmington Hospital
Wilmington, Delaware, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Saint Joseph Regional Medical Center
Lewiston, Idaho, United States
Kootenai Cancer Center
Post Falls, Idaho, United States
Kootenai Cancer
Sandpoint, Idaho, United States
Memorial Hospital of Carbondale
Carbondale, Illinois, United States
Centralia Oncology Clinic
Centralia, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
University of Illinois
Chicago, Illinois, United States
Saint Joseph Hospital
Chicago, Illinois, United States
Cancer Care Center of Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Crossroads Cancer Center
Effingham, Illinois, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, United States
Trinity Medical Center
Moline, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Mary Greeley Medical Center
Ames, Iowa, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States
McFarland Clinic PC-Boone
Boone, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Mercy Cancer Center-West Lakes
Clive, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge, Iowa, United States
McFarland Clinic PC-Jefferson
Jefferson, Iowa, United States
McFarland Clinic PC-Marshalltown
Marshalltown, Iowa, United States
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Methodist West Hospital
West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes
West Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas-Manhattan
Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States
Via Christi Regional Medical Center
Wichita, Kansas, United States
Wichita CCOP
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
Eastern Maine Medical Center
Bangor, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States
Saint John Hospital and Medical Center
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Grand Rapids Clinical Oncology Program
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
Allegiance Health
Jackson, 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
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
Community Cancer Center of Monroe
Monroe, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Community Hospital
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States
Spectrum Health Reed City Hospital
Reed City, Michigan, United States
Saint Mary's of Michigan
Saginaw, Michigan, United States
Lakeland Hospital
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
Health Partners Inc
Minneapolis, Minnesota, United States
New Ulm Medical Center
New Ulm, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Phelps County Regional Medical Center
Rolla, Missouri, United States
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint John's Mercy Medical Center
St Louis, Missouri, United States
Montana Cancer Consortium CCOP
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Billings Clinic
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Nebraska Hematology and Oncology
Lincoln, Nebraska, United States
Nebraska Cancer Research Center
Lincoln, Nebraska, United States
Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States
Oncology Hematology West
Omaha, Nebraska, United States
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States
Oncology Hematology West PC
Omaha, Nebraska, United States
Urology Cancer Center PC
Omaha, Nebraska, United States
Creighton University Medical Center
Omaha, Nebraska, United States
New York Oncology Hematology PC - Albany
Albany, New York, United States
New York Oncology Hematology PC -Albany Medical Center
Albany, New York, United States
New York Oncology Hematology PC-Hudson
Hudson, New York, United States
New York Oncology Hematology PC - Latham
Latham, New York, United States
Orange Regional Medical Center
Middletown, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
New York Oncology Hematology PC - Troy
Troy, New York, United States
Randolph Hospital
Asheboro, North Carolina, United States
Southeastern Medical Oncology Center-Clinton
Clinton, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville
Jacksonville, North Carolina, United States
Kinston Medical Specialists PA
Kinston, North Carolina, United States
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States
Southeastern Medical Oncology Center-Wilson
Wilson, North Carolina, United States
Akron General Medical Center
Akron, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
University Pointe
West Chester, Ohio, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Tulsa Cancer Institute
Tulsa, Oklahoma, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Western Oncology Research Consortium
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Adams Cancer Center
Gettysburg, Pennsylvania, United States
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Oncology at Evangelical Community Hospital
Lewisburg, Pennsylvania, United States
Lewistown Hospital
Lewistown, Pennsylvania, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States
Geisinger Medical Oncology-Pottsville
Pottsville, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
WellSpan Health-York Hospital
York, Pennsylvania, United States
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States
Greenville Memorial Hospital
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, United States
Wellmont Medical Associates Oncology and Hematology-Johnson City
Johnson City, Tennessee, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Wellmont Medical Associates Oncology and Hematology-Kingsport
Kingsport, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
Meharry Medical College
Nashville, Tennessee, United States
University Medical Center Brackenridge
Austin, Texas, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Southwest VA Regional Cancer Center
Norton, Virginia, United States
Auburn Regional Medical Center
Auburn, Washington, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Providence Regional Cancer System-Lacey
Lacey, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Saint John Medical Center
Longview, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
Capital Medical Center
Olympia, Washington, United States
Good Samaritan Community Hospital
Puyallup, Washington, United States
Allenmore Hospital
Tacoma, Washington, United States
Northwest CCOP
Tacoma, Washington, United States
Northwest Medical Specialties PLLC
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
Multicare Health System
Tacoma, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
West Virginia University Charleston
Charleston, West Virginia, United States
West Virginia University Healthcare
Morgantown, West Virginia, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Froedtert and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin, United States
Aspirus Regional Cancer Center
Wausau, Wisconsin, United States
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Big Horn Basin Cancer Center
Cody, Wyoming, United States
Billings Clinic-Cody
Cody, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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Other Identifiers
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NCI-2013-00357
Identifier Type: REGISTRY
Identifier Source: secondary_id
E1311
Identifier Type: -
Identifier Source: org_study_id
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