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Title   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
Study Number   E1311
Trial Type   Oncology-Head and Neck
Trial Status   Open to Accrual
Principal Investigator   Marshall Levine¬ł MD
Contact¬†Name   Brendan Costello
Phone   (443) 849-3122



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.



- Disease Free Survival



Drug: afatinib - Given PO

Other Names: BIBW 2992, dual tyrosine kinase inhibitor BIBW 2992, EGFR/HER2 TKI BIBW 2992, EGFR/HER2 tyrosine kinase inhibitor BIBW 2992

Other: placebo - Given PO

Other Name: PLCB

Other: laboratory biomarker analysisCorrelative studies



Experimental: Arm I (afatinib)

Patients receive afatinib PO QD on days 1-28.


          Drug: afatinib

          Other: laboratory biomarker analysis

Placebo Comparator: Arm II (placebo)

Patients receive placebo PO QD on days 1-28.


          Other: placebo

          Other: laboratory biomarker analysis






-  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

-  Must be 18 years and older

-  Patients must have pathological evidence of persistent lymph node disease with viable tumor cells following primary concurrent chemoradiotherapy of locoregionally advanced (stage III/IV) head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, or hypopharynx; persistent 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 hematoxylin 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

-  Patients must have achieved a complete response at the primary disease site after chemoradiotherapy

-  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 will be eligible

-  Patients must be at least 6 weeks (42 days) and no more than 16 weeks (112 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

-  Patients with known persistent disease at the primary mucosal site (even if resected after chemoradiotherapy), distant metastatic disease or with any gross residual disease following neck dissection will not be eligible

-  Patients with known hypersensitivity to afatinib or any of the excipients of this product will be excluded

-  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

-  No prior adjuvant chemotherapy (aside from the initial induction chemotherapy followed by chemoradiotherapy or chemoradiotherapy regimen) will be permitted

-  Patients with history of acute myocardial infarction within 3 months prior to registration, and any history of uncontrolled angina, uncontrolled arrhythmia, or uncontrolled heart failure will be excluded

-  Women must not be pregnant or breast-feeding due to potential harm to the fetus and baby by afatinib; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

-  Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception

-  Patients with active infections, other cancers, or history of other cancers will be excluded

-  Patients participating in any other clinical trials or taking any other experimental medications will be excluded

-  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

-  Patients with left ventricular dysfunction will be excluded

-  Patients with evidence of interstitial lung disease will be excluded



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