Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, single arm, open-label Phase 1/2 study of pemetrexed plus cisplatin for patients with unresectable, advanced gastric cancer who had no prior palliative chemotherapy. Phase 1 was designed to determine the optimal dose of pemetrexed for its phase 2, which has been completed and now a total of 60 qualified patients will be enrolled in the phase 2 of this study. The treating physician will determined the maximum number of cycles of pemetrexed plus cisplatin that a patient may receive in this study.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Pemetrexed

Criteria

Inclusion Criteria:

• Histological proven diagnosis of adenocarcinoma of the stomach

• Stage IV disease not amenable to curative surgery.

• Disease status must be that of measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

• Performance status of 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale.

• Adequate organ functions

Exclusion Criteria:

• Prior palliative chemotherapy for advanced gastric cancer.

• Pregnancy and breast feeding.

• Known or suspected brain metastasis and secondary primary malignancy

• Inability to interrupt aspirin, or other non-steroidal anti-inflammatory agents for a 5-day period.

• Inability or unwillingness to take folic acid or vitamin B12 supplementation.

• Concurrent administration of any other tumor therapy.