NCT00192088

A Study of Pemetrexed Plus Oxaliplatin as First Line Therapy in Advanced Gastric Carcinoma

Open-Label Single-Arm Phase II Study of ALIMTA in Combination With Oxaliplatin as First-Line Therapy in Advanced Gastric Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (planned)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open label single arm phase II study of Pemetrexed plus Oxaliplatin in patients with advanced gastric carcinoma not previously treated with palliative chemotherapy. 43 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: 6 cycles/21 days of Pemetrexed 500 mg/m2 followed by Oxaliplatin 120 mg/m2. This study will also include pharmacogenomic and pharmacogenetic investigations in order to assess determinants of efficacy and toxicity of the treatment with Pemetrexed and Oxaliplatin in the study population.

Conditions

• Advanced Gastric Carcinoma

Interventions

Type	Name	Description
DRUG	pemetrexed
DRUG	oxaliplatin

Timeline

• Start date: 2004-05-01
• Completion: 2006-05-01
• First posted: 2005-09-19
• Last updated: 2007-01-26

Locations

13 sites across 1 country: Italy