Celecoxib/Oxaliplatin/Capecitabine for Gastric/Gastroesophageal Junction Carcinoma
Status:
Terminated
Trial end date:
2007-08-01
Target enrollment:
Participant gender:
Summary
Gastric cancer is the second most common neoplasm in the world. Early diagnosis and surgical
resection improve the survival and the chance of cure. Unfortunately, majority of cases are
diagnosed at advanced stage, with only 20% of the patients presenting with localized disease.
The five-year survival for gastric cancer of all stages remains at a dismal 8%. Chemotherapy
has been used for advanced gastric cancer but with unsatisfactory results. Therefore, new
approaches are needed for these patients. Among the newer chemotherapy regimens for advanced
gastric cancer include a combination of oral 5-Fluoro-Uracil (FU)-based compound called
Capecitabine(Xeloda) and Oxaliplatin. A few phase II studies suggest that the combination
regimen is active with overall response rates ranging 30-40%. Several preclinical and
clinical studies have shown that the expression of cyclooxygenase enzyme II(COX-2) is
upregulated in many pre-neoplastic and neoplastic lesions. Furthermore, there appears to be
an association with the overexpression of Cox-2 and the invasiveness of cancer and prognosis.
Finally, preclinical and clinical studies suggest selective Cox-2 inhibitors can induce
apoptosis in gastric cancer cells and retard tumor progression. Therefore, there is a strong
rationale for the combination of a selective Cox-2 inhibitor, Celecoxib, with Capecitabine
and Oxaliplatin in a therapeutic phase II trial for patients with advanced or recurrent
gastric cancer.