A Phase II Study of Pazopanib in Combination With Capecitabine and Oxaliplatin (CAPEOX) in Patients With Advanced Gastric Cancer
Despite improvements in the early diagnosis of gastric cancer, many patients present with
inoperable disease and an effective, novel combination treatment is urgently needed for
these patients population. A recent meta-analysis demonstrated that chemotherapy improves
survival for patients with advanced gastric cancer compared with best supportive care alone
[hazard ratio (HR) 0.39, 95% confidence interval (CI) 0.28-0.52] and that combination
chemotherapy is superior to monotherapy (HR 0.83, 95% CI 0.74-0.93) (Wagner et al., 2006).
For advanced gastric cancer, 5-FU in combination with cisplatin (FP regimen) is commonly
used reference regimen, which are successfully replaced by capecitabine and oxaliplatin in
recent phase III trial (Cunningham et al., 2008; Okines et al., 2009). In phase II trial,
CAPEOX (capecitabine combined with oxaliplatin) regimen also showed promising activity for
the metastatic gastric cancer (Park et al., 2006; Park et al., 2008). In order to improve
survival of metastatic gastric cancer patients, various clinical trials incorporated novel
molecularly targeted agent in combination with the reference arm.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
6 months after last patient
Joon Oh Park, M.D., Ph.D.
Samsung Medical Center
Korea: Food and Drug Administration