Phase 2 Study of Adjuvant Chemotherapy With Docetaxel, Capecitabine and Cisplatin in Patients With Advanced Gastric Cancer
Previous in phase II study of docetaxel, capecitabine and cisplatin,total 40 pts with
measurable disease, median 6 cycles of chemotherapy, there were 4 confirmed complete
responses (CRs) and 23 confirmed partial responses (PRs), with the overall response rate of
67.5% (95% confidence interval, 52.7 ~ 82.3) in intention-to-treat analysis. Ten patients
underwent surgical resection after 4 ~ 9 cycles of chemotherapy. Four pathologic CRs were
identified. With a median follow-up of 14 months (range, 1 to 28), median time to
progression was 7.7 months, and median overall survival was 16.9 months. The DXP
chemotherapy was highly active for the 1st-line chemotherapy of AGC (Kang et al, Proc Am Soc
Clin Oncol 22,328.2003).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
This protocol will evaluate the possible benefit of adjuvant docetaxel, capecitabine, and cisplatin combination chemotherapy in patients with resected gastric cancer pathologic stage IIIB and IV in terms of relapse free survival.
Yoon-Koo Kang, MD, PhD
Asan Medical Center
Korea: Food and Drug Administration