BIBW 2992 (Afatinib) in Head & Neck Cancer

Exclusion Criteria

• •1. Progressive disease within 3 months after completion of curative intent treatment for localized/locoregionally advanced disease.
• •2. Prior use of an EGFR or erbB2 inhibitor in the recurrent/metastatic disease setting (treatment with cetuximab (Erbitux®) or other EGFR inhibitor during radiotherapy or chemoradiotherapy is permissible).
• •3. More than 2 chemotherapeutic regimens given for recurrent/metastatic disease.
• •4. Treatment with other investigational drugs, other anti-cancer-therapy (e.g., chemotherapy, immunotherapy, radiotherapy), concomitantly with therapy on this study and/or during the last four weeks, prior to the first treatment with the trial drug
• •5. eliminated per Amendment #1
• •6. Patients with history of other malignancy (except for appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least 3 years.
• •7. Patients with history of decompensated heart failure.
• •8. Cardiac left ventricular function with resting ejection fraction \<50% or less than the institutional lower limit of normal by MUGA or echocardiogram.
• •9. Active infectious disease.
• •10. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
• •11. Serious illness, concomitant non-oncological disease or mental problems considered by the investigator to be incompatible with the protocol.
• •12. Use of alcohol or drugs incompatible with patient participation in the study in the investigator's opinion.
• •13. Patients unable to comply with the protocol.
• •14. Patients with active/symptomatic brain metastases. Patients with a history of treated brain metastases must have stable or normal cerebral MRI scan at screening and be at least three months post-radiation or surgery.
• •15. Absolute neutrophile count (ANC) less than 1000/mm3.
• •16. Platelet count less than 75,000/mm3.
• •17. Bilirubin greater than 1.5 mg/dl/ Higher bilirubin values are acceptable for patients with known Gilbert's disease, approval by the PI and sponsor necessary.
• •18. Asparate amino transferase (AST) or alanine amino transferase (ALT) greater than 3 times the upper limit of normal.
• •19. Serum creatinine greater than 1.5 X upper limit of normal for the institution.
• •20. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
• •21. Pregnancy or breast-feeding.
• •22. Patients with known pre-existing interstitial lung disease.