Advanced or recurrent esophageal cancer
Conditions
Interventions
Paclitaxel (100mg/m2, 1-h intravenous infusion) is administered on day1, 8, 15, 22, 29 and 36, repeated every 7 weeks.
Sponsors
University of Miyazaki Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of the esophagus 2)Advanced (stage IV) or recurrent esophageal cancer who had previously received docetaxel-containing chemotherapy 3)Adequate recovery from prior systemic therapy as follows: >=4 weeks post-radiation therapy; >=4 weeks post-chemotherapy and surgical therapy; >=2 weeks post-treatment with antimetabolic drugs 4)Patients with measurable lesions 5)ECOG performance status of 0 to 1 6)Adequate organ functioing of major organ systems as indicated by the following laboratory parameters: neutrophils >=1,500/mm3; platelets>=100,000/mm3; hemoglobin>=9.0g/dL; AST and ALT levels<=100IU/L; total bilirubin <=1.5mg/dL; and serum creatinin <=2.0mg/dL 7)A life expectancy of >=2 months 8)Age 20 years old or more 9)HBs antigen negative 10)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Pregnant or lactating women 2)Symptomatic brain metastasis 3)Synchronous or metachronous (within 5 years) malignancies except for mucosal tumors of gastrointestinal tract 4)Severe complications (serious cerebrovascular disorders, uncontrollable hypertension, uncontrollable diabetes mellitus, active ulceration) 5)Active bacterial or fungous infection 6)Interstitial pneumonitis or pulmonary fibrosis 7)Massive pleural effusion or massive ascites 8)Past histrory of myocardial infarction and angina attack within 6 months 9)Past histrory of congested heart failure 10)Arhythmia requiring treatment 11)Peripheral neuropathy grade >=2 by CTCAE v4.0 12)With a history of allergic reaction to polyoxyethylene castor oil or hydrogenated castor oil 13)Serious psychiatric disease 14)Systemic steroids medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression-free survival, adverse events | — |
Countries
Japan
Contacts
Public ContactAyumu Hosokawa
University of Miyazaki Hospital Department of Clinical Oncology
Outcome results
None listed