Phase 1/2 Study of Pemetrexed Plus Cisplatin in Unresectable, Advanced Gastric Carcinoma.
- 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
- 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
- Inability or unwillingness to take folic acid or vitamin B12 supplementation.
- Concurrent administration of any other tumor therapy.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Best Tumor Response
Outcome Time Frame:
baseline to measured progressive disease (Tumor assessments were performed every 2 cycles during therapy and 6-8 weeks during post-therapy until disease progression, or up to 12 months after enrollment)
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559, Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Taiwan: Department of Health
- Neoplasm, Gastric
- Stomach Neoplasms