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
Status: | Active, not recruiting |
---|---|
Conditions: | Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/3/2019 |
Start Date: | July 2013 |
End Date: | December 2020 |
A Randomized Placebo Controlled Phase II Trial of Afatinib (BIBW2992) as Adjuvant Therapy Following Chemoradiation in Patients With Head and Neck Squamous Cell Carcinoma at High Risk of Recurrence
This randomized phase II trial studies how well giving afatinib after chemoradiation and
surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and
neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking some
of the enzymes needed for cell growth.
surgery works in treating patients with stage III-IV squamous cell carcinoma of the head and
neck at high-risk of recurrence. Afatinib may stop the growth of tumor cells by blocking some
of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
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.
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.
Inclusion Criteria:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- 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:
- Patients with known distant metastatic disease or with any gross residual disease
following salvage primary tumor resection or neck dissection
- 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
We found this trial at
272
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Saint Charles Hospital Since 1953, Mercy St. Charles Hospital has been providing for the healthcare...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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4805 Northeast Glisan Street
Portland, Oregon 97213
Portland, Oregon 97213
(503) 215-1111
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Michigan Cancer Research Consortium Community Clinical Oncology Program The Community Clinical Oncology Program (CCOP) is...
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Randolph Hospital Since 1932, Randolph Hospital has been fortunate to employ dedicated and loyal personnel...
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Billings Clinic Based in Billings, Montana, Billings Clinic is a community-governed health care organization consisting...
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Montana Cancer Consortium CCOP The Montana Cancer Consortium is a nonprofit organization whose mission is...
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Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
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Albert Einstein College of Medicine The Albert Einstein College of Medicine of Yeshiva University is...
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Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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400 South Clark Street
Butte, Montana 59701
Butte, Montana 59701
406-723-2500
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
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Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
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Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
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Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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1969 W Ogden Ave
Chicago, Illinois 60612
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(312) 864-6000
John H. Stroger, Jr. Hospital of Cook County The Level 1 Trauma Center is one...
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9280 SE Sunnybrook Blvd #100
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Clackamas, Oregon 97015
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Clackamas Radiation Oncology Center State-of-the-art technology and compassionate care come together at Clackamas Radiation Oncology...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Mercy Cancer Center - West Lakes When it comes to cancer care, there
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Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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Iowa Oncology Research Association CCOP The Iowa Oncology Research Association (IORA) was established by a...
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Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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Fredericksburg Oncology Inc Fredericksburg Oncology is dedicated to offering each patient individual care and attention...
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Unity Hospital Unity Hospital is one of the Twin Cities
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Adams Cancer Center Every day across central Pennsylvania, the people of WellSpan Health work together...
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25 Michigan St. NE, Suite 3100
Grand Rapids, Michigan 49503
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Grand Rapids Clinical Oncology Program GRCOP initially formed to develop community cancer patient management guidelines....
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Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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1117 29th St S
Great Falls, Montana 59405
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Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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