For the gastric cancer, paclitaxel is recommended as salvage standard treatment. Afatinib is a novel, potent, small ErbB family blocker that covalently binds and irreversibly blocks signaling through activated EGFR, HER2 and ErbB4 receptors, as well as the transphosphorylation of ErbB3. The investigators suggest a randomized phase II trial of afatinib plus weekly taxol(paclitaxel) for previously treated EGFR positive gastric cancer patients. The aim of current trial is to evaluate the antitumor efficacy of afatinib for target enriched patients in gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Afatinib 40mg daily oral administration
Paclitaxel 80mg/m2 IV weekly (day 1,8,15)
Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
Seoul, South Korea
compare progression free survival as measured by RECIST 1.1
To identify antitumor activity of afatinib plus weekly taxol(paclitaxel) and explore predictive biomarker
Time frame: Every 6 weeks until progression, an expected average of 10 months
antitumor efficacy as measured by RECIST 1.1
Time frame: every 6 weeks until progression, an expected average of 10 months
safety as measured by CTCAE
Time frame: every 3 weeks until progression, an expected average of 10 months
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