A Phase II Trial of Afatinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of Esophagus

Inclusion Criteria

• •Histologically or cytologically confirmed squamous cell carcinoma of esophagus
• •Age ≥ 20
• •ECOG PS 0-2
• •Ineligibility for local therapy (surgery or radiotherapy)
• •Patients who have failed to respond to or receive a first-line, palliative platinum-based chemotherapy
• •1. Allowed to enroll the patients who have developed the recurrent cancer within 6 months after definitive/neo-adjuvant/adjuvant platinum-based chemotherapy(± radiotherapy), by considering the prior therapy as first-line chemotherapy.
• •2. Allowed to enroll the patients who cannot undergo platinum-based chemotherapy or concurrent chemo-radiotherapy due to concern for renal function deterioration and the patient intolerance, without prior chemotherapy history.
• •At least one bidimensionally measurable disease as defined by RECIST ver 1.1
• •Adequate organ function for treatment
• •1. Absolute neutrophil count (ANC) \>=1000 cells/mm3
• •2. Platelets ≥ 100,000 cells/mm3
• •3. Estimated creatinine clearance ≥50 mL/min, or serum creatinine \<1.5 x institution upper limit of normal (ULN) using Cockcroft and Gault formulas
• •4. Bilirubin ≤1.5 x ULN
• •5. AST (SGOT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
• •6. ALT (SGPT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases)
• •7. 12-Lead electrocardiogram (ECG) with normal tracing or nonclinically significant changes that do not require medical intervention QTc interval ≤470 msec and without history of Torsades de Pointes or other symptomatic QTc abnormality
• •The patient who has signed the informed consent prior to conducting study related screening procedures, and who understands that the study may be discontinued at anytime without disadvantages