advanced or recurrent esophagogastric carcinoma
Conditions
Interventions
docetaxel and 5-fluorouracil
Sponsors
Kitasato University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed esophageal or gastric carcinoma. 2. measurable or evaluable lesion 3. this chemotherapy is second or third line 4. No previous use of Taxan 5. Performance Status:0-2(ECOG) 6. Patients of age =>20 at the registration 7. Life expectancy more than 12 weeks 8. Sufficient organ functions within two weeks before registration 1) leukocytes =>3,000/mm3 2) neutrocytes =>1,500/mm3 3) platelets =>100,000/mm3 4) hemoglobin =>8.0g/dl 5) AST(GOT)/ALT(GPT) <=100IU/l 6) total bilirubin <=1.5mg/dl 7) serum creatinine <=1.50mg/dl 8) normal ECG 9. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Administration of the blood transfusion or G-CSF within 7 days before registration 2. History of serious drug hypersensitivity 3. Active infection 4. Watery diarrhea 5. Uncontrolled ileus 6. Active gastrointestinal bleeding 7. Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe pulmonary emphysema or etc) 8. Symptomatic brain metastasis 9. Active synchronous or metachronous malignancy, excepting for esophageal and gastric carcinoma 10. Severe abnormality of ECG, severe heart disease (congestive heart failure, symptomatic ischemic heart disease, uncontrolled arrhythmia, history of myocardial infarction within 12 months, or etc) 11. Severe mental disorders, neurological disease 12. Pregnant or lactation women, or women with the possibility of the pregnancy and men who want let to pregnancy 13. Patients who are judged inappropriate for the entry into this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To estimate the maximum tolerated dose and the recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy | — |
Countries
Japan
Outcome results
None listed