Aspirus Regional Cancer Center

Cancer Clinical Trials

This is a current listing of active clinical trials at the Aspirus Regional Cancer Center. From this list you can select a specific cancer that you are interested in (for example, breast or colon cancer) and then review the clinical trials that are active at the Aspirus Regional Cancer Center for that specific disease.

Head and Neck

Trial Name: 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.

Protocol ID: E1311

Eligibility:

  • Age 18 yrs. of age and older.
  • Patients must have pathological evidence of persistent lymph node disease with viable tumor cells following primary concurrent chemoradiotherapy of locoregionally advanced Head and Neck Squamous Cell Carcinoma (HNSCC) of the oral cavity, oropharynx, larynx, or hypopharynx.
  • Patients must meet required laboratory values
  • Patients with known hypersensitivity to afatinib or any of the excipients of this product will be excluded.
  • Prior cetuximab or any EGFR inhibitors will not be permitted including cetuximab administered with a chemoradiotherapy or radiotherapy regimen.
  • No prior adjuvant chemotherapy (aside from the initial induction chemotherapy followed by chemoradiotherapy or chemoradiotherapy regimen) will be permitted.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus and baby by afatinib. 
  • 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, or history of other cancers will be excluded.

Enrollment: 108 will be enrolled

Benefits:

Taking part in this study may or may not make your health better.  While doctors hope afatinib will be more useful against cancer compared to the usual treatment, there is no proof of this.  We do know that the information from this study will help doctors learn more about afatinib as a treatment for cancer.  This information could help future cancer patients.

Contact:

These clinical trial overviews are intended to provide a brief overview of the clinical trial. To help determine whether the trial is appropriate for you, the major eligibility criteria are listed above. To obtain more information on the eligibility and the treatment plan, please contact our Aspirus Regional Cancer Center Oncology Clinical Research Coordinator, Beth Knetter at 715-847-2353 or 1-800-283-2881, ext.72353, or Langlade Cancer Center Research Nurse Debra Witman @ 715-623-9587.

Created: Feb 24, 2014

Updated: May 21, 2014

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