A Phase 2 interventional study of pemetrexed and cisplatin in Gastrointestinal Neoplasms, sponsored by Eli Lilly and Company. Completed at 3 sites in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2007-01-26.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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.
2,850 studies on the registry are indexed under Stomach Neoplasms; 863 are open to participants now.
This study's enrollment of 50 is below the median of 67 across 2,095 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 141 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Response rate according to RECIST criteria
The following time to event efficacy measures:
o Duration of overall response for responding patients
o Time to documented progressive disease
o Time to treatment failure
o Overall survival
The quantitative and qualitative toxicity of pemetrexed plus cisplatin in this patient population
This study is completed, as verified in Jan 2007. You cannot join it, but the record below documents what was studied.
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