advanced gastric cancer
Conditions
Interventions
TS1: 80 mg/body/day, orally 21days, every 5 weeks Docetaxel: 15, 20, 25, or 30 mg/m2, day 1, 8, 15, every 5
Sponsors
Department of Medical Oncology, Kinki University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Gastric cancer 2) At least one measurable lesion 3) Inoperable or relapsed gastric cancer 4) Prior 2 regimens of chemotherapy and no prior treatment of TS1 or docetaxel 5) Age > 20 years 6) Performance status (PS) of 0 to 1 7) Adequate main organ functions WBC > 4000/mm3, 100000/mm3 Hb > 8.0g/dl GOT/GPT < 2.5 x normal range Serum creatinine < 1.5mg/dl 8) Normal ECG (NCI-CTC < Grade 1) 9) Aural ingestion 10) Estimation of at least 3 months survival 11) Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decision of the recommended dose of TS1 and docetaxel | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination of dose limited toxicity and response and safety of the combination of TS1 and docetaxel | — |
Countries
Japan
Outcome results
None listed