A phase I trial of combination chemotherapy with docetaxel and 5-fluorouracil (DF) for advanced esophagogastric carcinoma (KDOG 0902 P1)
- Conditions
- advanced or recurrent esophagogastric carcinoma
- Registration Number
- JPRN-UMIN000002041
- Lead Sponsor
- Kitasato University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To estimate the maximum tolerated dose and the recommended dose
- Secondary Outcome Measures
Name Time Method safety efficacy