Phase I/II study of weekly chemotherapy consisting of 5-FU, leucovorin, and Paclitaxel (FLTAX) in patients with metastatic or recurrent gastric cancer.

UMIN ID: UMIN000000502

Registered date:14/10/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with metastatic or recurrent gastric cancer
• Date of first enrollment: 2006/07/01
• Target sample size: 35
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 5-FU Level 0 : 400mg/m2 bolus Level 1,2: 500mg/m2 bolus Level 3,4: 600mg/m2 bolus l-Leucovorin Level 0 : 200mg/m2/120min Level 1-4: 250mg/m2/120min Paclitaxel Level 0,1: 60mg/m2/60min Level 2,3: 80mg/m2/60min Level 4 : 100mg/m2/60min Administer three drugs on day1,8,15. Repeat every 4 weeks.

Outcome(s)

• Primary Outcome: Phase I : Rate of dose limiting toxicity Phase II: Response rate
• Secondary Outcome: Toxicity Time to treatment failure Overall survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Diabetes with regular use of insulin or under poor control 2) Active ischemic heart disease 3) Severe arrhythmia 4) Symptomatic brain metastasis 5) Alcohol allergy 6) HBs antigen positive or HCV antibody positive 7) Massive abdominal effusion 8) Massive pleural effusin 9) Severe diarrhea 10) History of other active malignancy 11) Pregnancy, the desire to preserve fecundity, or lactating woman 12) Severe mental disorder 13) Need of IVH or enteral nutrition 14) Inadequate physical condition, as diagnosed by primary physician

Related Information

• Primary Sponsor: National Cancer Center Hospital, Gastrointestinal Oncology Division
• Source(s) of Monetary Support: Ministry of Health, Labor and Welfare