Phase I/II Study of Taxotere,CDDP and 5-FU(TPF) in Pre-treated Pts With Metastatic Esophageal Cancer.
Esophageal Cancer
About this trial
This is an interventional treatment trial for Esophageal Cancer
Eligibility Criteria
Inclusion Criteria: Histologically confirmed metastatic or recurrent esophageal tumors with previous treatment for advanced disease.(Except for small cell carcinoma) At least one measurable lesion according to the RECIST criteria. Minimum indicator lesion size: > 10 mm measured by spiral CT or >20mm measured by conventional techniques(Except for Phase I setting). Patients aged between 20 and 75 years, inclusive, at the time of acquisition of informed consent Patients with performance status(ECOG) 0 to 2 Abnormal hematologic values (WBC ≥ 3.5 x 109/L, Hemoglobin ≥ 9.5g/dl, platelet count ≥ 100 x 109/L) Creatinine clearance ≥ 60 ml/min, Serum cleatinine ≤ 1.5mg/dl Serum bilirubin ≤ 1.5mg/dl. ALT, AST ≤ 2.5 x upper normal limit (or ≤ 3 x upper normal limit in the case of liver metastases) Patients who have received 1cycle cancer therapy (radiotherapy, chemotherapy or chemoradiotherapy) given > 4 weeks prior to the beginning of study therapy Life expectancy ≥ 3 months Patients who have given written informed consent to participate in this study Exclusion Criteria: Patients with active multiple cancers; or even if the multiple cancers are metachronous, have a disease-free period of less than 5 years (but excluding cancer in situ and skin cancer) (Except for Phase I setting) Serious, uncontrolled, concurrent infection(s) or illness(es) Patients with no serious concurrent complications (such as heart disease, Intestinal pneumonia) Patients with brain metastasis Patients receiving continuous administration of steroids Patients who have experienced serious drug allergy in the past Patients with retention of body fluid(pleural effusion, ascites, pericardial effusion) necessitating treatment Patients who are pregnant and lactating or hope to become pregnant during the study period Patients with prior Taxan treatment (Paclitaxel, Docetaxel) Patients with edema ≥ grade 2 Others, patients judged by the investigator or subinvestigator to be inappropriate as subject
Sites / Locations
- ・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)
Arms of the Study
Arm 1
Experimental
1