A phase I study of TS-1 and docetaxel for advanced gastric cancer

UMIN ID: C000000188

Registered date:12/09/2005

Basic Information

• Recruitment status: Suspended
• Health condition(s) or Problem(s) studied: advanced gastric cancer
• Date of first enrollment: 2002/12/01
• Target sample size: 15
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): TS1: 80 mg/body/day, orally 21days, every 5 weeks Docetaxel: 15, 20, 25, or 30 mg/m2, day 1, 8, 15, every 5

Outcome(s)

• Primary Outcome: Decision of the recommended dose of TS1 and docetaxel
• Secondary Outcome: Determination of dose limited toxicity and response and safety of the combination of TS1 and docetaxel

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1) History of active other malignancy 2) Severe heart disease (uncontrolled angina pectoris,myocardial infarction,heart failure within 3 months 3) Uncontrolled diabetes and hypertension 4) Severe complication (infection, bowel obstruction,or hemorrhage etc.) 5) > G2 neuropathy 6) Massive pleural,cardiac,or abdominal effusion 7) Intestinal fresh hemorrhage 8) Symptomatic brain metastasis 9) Pregnant women or women willing child-bearing 10) History of severe drug allergic reaction 11) Limitation of use of TS1 or docetaxel 12) Inadequate condition diagnosed by primary physician

Related Information

• Primary Sponsor: Department of Medical Oncology, Kinki University School of Medicine
• Source(s) of Monetary Support: Department of Medical Oncology, Kinki University School of Medicine