Clinical Trial of Chemotherapy Combination Cisplatin-Fluorouracil-Afatinib in Patients With Inoperable Gastric Cancer
Status:
Completed
Trial end date:
2019-07-29
Target enrollment:
Participant gender:
Summary
The purpose of this study is to evaluate the efficacy and safety of the combination of
Cisplatin,5-Fluorouracil(5FU) and Afatinib as first-line therapy in patients with advanced
gastric or gastroesophageal junction cancer. The study will include 55 patients in all. The
patients will receive open-label Cisplatin intravenous 75mg/m2 on Day 1, 5FU 750mg/m2 at
24-hour intravenous infusion on Days 1-4, and Afatinib 40mg per os on Days 3-5, 8-12, 15-19.
The administration of Afatinib will start on Day 3 of each therapy cycle with an
administration interval on each weekend ("Weekday on, Weekend off") for 21 days. Instructions
are given on the dose reduction scheme in the presence of toxicity. The administration of the
combination Cisplatin-5FU-Afatinib will be continued until disease progression, appearance of
significant toxicity, completion of 6 treatment cycles, or withdrawal of consent. At
completion of 6 cycles of the combination, in the absence of disease progression, the
administration of Afatinib as maintenance monotherapy will be continued until disease
progression, appearance of significant toxicity, or withdrawal of consent at the weekday
on-weekend off schedule. Imaging will be applied once every 8 weeks, and once every 12 weeks
in the Afatinib maintenance therapy phase.