Advanced Esophageal Cancer
Conditions
Interventions
Docetaxel: 70 mg/m2 on day 1 every 3 week
Paclitaxel: 100 mg/m2 on day 1,7, 14, 21, 28, 35 and subsequent 7 days rest, repeat every 7 week
Sponsors
Osaka Gastrointestinal cancer chemotherapy Study Group (OGSG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed esophageal squamous/adenosquamous cancer 2) Advanced and/or recurrent esophageal cancer resistant to fluoropyrimidine and/or platinum compound 3) Without prior chemotherapy using Taxans (Docetaxel or Paclitaxel) 4) The age of 20 or over and under the age of 80 5) PS(ECOG) 0,1 or 2 6) expected survival longer than 3 months from the start of regimen 7) a treatment interval longer than 14 days 8) Adequate baseline organ and marrow function as defined below by a test within 7 days of registration; a)Leukocytes: 3,500-12,000 /mm3 b)Absolute neutrophil count: >=2,000 / mm3 c)Platelets: >=100,000 / mm3 d)Hemoglobin: >=9.0 g/dL e)AST (SGOT)/ALT (SGPT) < 100 IU/L f)Total bilirubin <1.5 mg/dL g)Serum creatine >=1.2 mg/dL h)Creatinine clearance: >=60 mL/min 9) with HBs Ag (-) confirmed by a test within 1 year of registration 10) Patients should sign a written informed consent 11) All the conditions by inspection within 7th before registration
Exclusion criteria
Exclusion criteria: 1) With active double cancers (Simultaneous and/or prior cancer within 5 years) Except cancers resected completely by ER/ESD 2) With uncontrolled DM 3) With cardiac infarction within 6 months or unstable angina pectoris 4) Patients who are administered anti-arhythmia except Warfarin 5) Patients who are administered steroids continuously orally and/or intravenously 6) Patient with liver cirrhosis 7) Patient with active infection 8) Patients with peri-cardiac fluid, pleural fluid and/or ascites which needs drainage Except controlled pleural fluid or ascites 9) With a history of grade 2-4 allergic reaction By CTCAE version 4.0 10) with a history of grade 2-4 nerve disturbance by CTCAE version 4.0 11) with blood transfusion within 2 weeks and/or continuous bleeding 12) with a figure of interstitial pneumonitis except radiation pneumonitis 13) with a history of allergic reaction to polyoxyethylene-castor oil, castor oil or polysolbate 80 14) with metastatic lesion in the central nerve system 15) patient with psychological disorder who cannot participate in this regimen 16) women pregnant and/or nursing or men who like to have children in future 17) Any patients judged by the investigator to be unfit to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival(OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Progression-free survival (PFS) Time to treatment failure (TTF) Response Rate (RR) | — |
Countries
Japan
Contacts
Public ContactSachiko Yamamoto
Osaka International Cancer Institute Department of Cancer Chemotherapy
Outcome results
None listed