NCT01824823|TerminatedPhase 2ResultsDMC

Study Stopped

Slow accrual

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

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

ECOG-ACRIN Cancer Research Group ClinicalTrials.gov

Compare

3 other identifiers

E1311NCI-2013-00357U10CA021115

Study Type

interventional

Target

Locations

1 country

Sites

272

Timeline

RegisteredApr 2013

StartedJun 2014

CompletionDec 2020

Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jun 2014

Longer than P75 for phase_2

Geographic Reach

1 country

272 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

First Submitted

Initial submission to the registry

April 2, 2013

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed

1.2 years until next milestone

Study Start

First participant enrolled

June 30, 2014

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2015

Completed

4 months until next milestone

Results Posted

Study results publicly available

April 4, 2016

Completed

4.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed

Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.5 years

First QC Date

April 2, 2013

Results QC Date

December 22, 2015

Last Update Submit

June 13, 2023

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

afatinibhead and neck squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

Disease-free Survival (DFS)
DFS is defined as the time from randomization to the earlier of disease recurrence, second primary cancer, or death without recurrence.
Assessed every 3 months for patients < 2 years from registration and every 6 months if patient is 2-3 years from registration and every 12 months if patient is 4-5 years from registration

Study Arms (2)

Arm A (afatinib)

EXPERIMENTAL

Patients receive afatinib PO QD on days 1-28.

Drug: afatinib

Arm B (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO QD on days 1-28.

Other: placebo

Interventions

afatinibDRUG

Given PO

Also known as: BIBW 2992

Arm A (afatinib)

placeboOTHER

Given PO

Arm B (placebo)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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
+4 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.