Afatinib, Paclitaxel, 2nd Line, Advanced Gastric Cancer

Inclusion criteria

• Histologically or cytologically confirmed locally advanced or metastatic gastric cancer and gastroesophageal junction cancer
• EGFR 2+ or 3+ expression (immunohistochemistry)
• ECOG performance status of 0 to 1
• Male or female; ≥ 19 years of age
• Documented disease progression after one prior therapy, in locally advanced or metastatic setting
• patients received last adjuvant chemotherapy less than six months can be enrolled into this study
• Her2 positive patients must be progressed after prior trastuzumab based chemotherapy
• Subjects with measurable lesion (using RECIST 1.1 criteria)
• Subjects who meet the following criteria:

• Absolute neutrophil count (ANC) ≥ 1000 /µL (*ANC = Neutrophil segs ＋ Neutrophil bands)
• Platelet count ≥ 80,000/ µL
• Serum creatinine < 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥50 mL/min using Cockcroft, Gault method
• AST (SGOT) and ALT (SGPT) : 3 x upper limit of normal (ULN) (If there is Liver Metastasis : 5 x upper limit of normal (ULN))
• Total bilirubin : 1.5 x upper limit of normal (ULN)
• Provision of written informed consent prior to any study procedure

Exclusion criteria

• Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy.
• Any previous chemotherapy or immunotherapy within 2 weeks
• Any major operation or irradiation within 4 weeks of baseline disease assessment
• Two or more previous systemic cytotoxic chemotherapy (adjuvant chemotherapy is not counted)
• Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
• Previously taxol(paclitaxel)-exposed patients
• Subjects with symptomatic central nervous system (CNS) metastases who are neurologically unstable or have required increasing doses of steroids within the 2 weeks prior to study entry to manage CNS symptoms
• Other co-existing malignancies or malignancies diagnosed within the last 3 years with the exception of basal cell carcinoma, thyroid cancer or cervical cancer in situ.
• Subjects with an uncontrolled major cardiovascular disease (including AMI within 12 months, unstable angina within 6 months, over NYHA class III congestive heart failure, congenital long QT syndrome, 2° or more AV Block and uncontrolled hypertension)
• Pregnant or lactating female
• Patients with contraindicated medication
• History of interstitial lung disease (ILD) or presence of ILD on chest X-ray
• Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study