Phase 2 Study on Use of a Combination of Pemetrexed in Patients With Advanced Gastric Carcinoma
Status:
Completed
Trial end date:
2005-09-01
Target enrollment:
Participant gender:
Summary
Pemetrexed has shown an anti-tumor activity in advanced gastric cancer patients in a previous
study, while cisplatin is widely used in the combination chemotherapy of gastric cancer.
Pemetrexed has shown synergy with cisplatin in preclinical models and in various human
cancers. The introduction of vitamin supplementation has made treatment with pemetrexed plus
cisplatin safe and well tolerated. The present phase 2 study is an effort to determine the
efficacy and safety of the combination of pemetrexed and cisplatin in Korean patients with
gastric carcinoma who had no prior palliative chemotherapy for advanced disease. The
patients, who will give their consent for participating in this study, will be screened for
their eligibility and on meeting pre-defined study eligibility criteria, they will receive an
intravenous therapy of the combination of pemetrexed and cisplatin for number of times that
in the opinion of their treating physician is appropriate for them. A response rate of 30% is
considered as the minimum activity level of interest for this patient population.