Study of S-1 Plus LV for Advanced Gastric Cancer

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.

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

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Taiho Pharmaceutical Co., Ltd.
• Treatments: Leucovorin; Tegafur

Criteria

Inclusion Criteria:

• histologically confirmed metastatic or recurrent gastric cancer

• with at least one measurable lesion by RECIST criteria

• an age of ≥ 18

• adequate oral intake

• no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if finished 6 months before enrollment)

• an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• adequate bone marrow function, hepatic function and renal functions

Exclusion Criteria:

• a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1

• serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)

• extensive bone metastasis, brain metastasis or meningeal metastasis

• another synchronous cancer

• surgery within 3 weeks before enrollment

• participating in other clinical studies

• women who were or to be pregnant, nursing infants, and men who were to conceive children