Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.

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.

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.