Study of Pemetrexed Plus Cisplatin in Advanced Gastric Cancer

Lilly

Status and phase

Completed

Phase 2

Phase 1

Conditions

Neoplasm, Gastric

Treatments

Drug: cisplatin

Drug: pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00320515

7461

H3E-AA-S038

Details and patient eligibility

About

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.

Enrollment

89 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.