A Phase I/II Trial of Docetaxel and Oxaliplatin in Patients With Advanced Gastric Cancer
Status:
Completed
Trial end date:
2008-06-01
Target enrollment:
Participant gender:
Summary
Gastric cancer is the most common malignancy in Korea. The prognosis of unresectable gastric
cancer has been improved by cytotoxic chemotherapy, but median survival rarely exceeds 1
year. New agents such as taxane, irinotecan and oxaliplatin combined with old agents such as
5-FU with or without leucovorin, doxorubicin, cisplatin showed higher response rates in phase
II studies. Docetaxel as a single agents showed response rates of 17-24%, and the combination
of docetaxel and cisplatin has shown a response rate of 37-56% and overall survival of 9-10.4
months. Oxaliplatin in combination with 5-FU and leucovorin(FOLFOX-6) showed an objective
response rate of 50%, which included a 4% complete response. The preclinical studies,
oxaliplatin has shown additive or synergistic cytotoxic properties with fluoropyrimidines,
thymidylate synthase inhibitors, topoisomerase I inhibitors, microtubule inhibitors and DNA
modifying/alkylating agents. The combination of docetaxel and oxaliplatin has been studied
previously in the phase I setting in patients with metastatic breast and non-small cell lung
cancer. The combination of docetaxel and oxaliplatin is a feasible and well tolerated
regimen. Recommended doses were 75mg/m2 for docetaxel on day 1 and 70mg/m2 for oxaliplatin on
day 2 without G-CSF support. The aim of this trial is to determine the dose limiting
toxicities, maximum tolerated dose(MTD) and efficacy of oxaliplatin and docetaxel as
combination chemotherapy in patients with advanced gastric cancer.