Esophageal cancer
Conditions
Interventions
Phase 1 part: The dose of docetaxel is initially set at 10mg /m2/day (level1) and the number of cases is increased and the dose escalation is increased by5mg/m2/day according to the expression status
Sponsors
The Jikei University school of medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The primary lesion is either cervical or thoracic esophagus (TNM classification). 2) Histopathologically it has been diagnosed as squamous cell carcinoma. 3) FP therapy refractory / intolerance. 4) The age of the registration date is 20 years old to 80 years old. 5) ECOG Performance status is 0 to 2. 6) Organ function is maintained. 7) There is no symptomatic brain metastasis. 8) Patients with a history of operation had esophageal cancer for total esophageal cancer cases in which more than 2 weeks had passed since gastric tube reconstruction 9) Cases in which survival is predicted to be at least 3 months or more from the date of registration 10) Cases in which an examination value within 14 days before registration (not including the registration date) satisfies the following criteria Hemoglobin 8.0 g / dL or more White blood cell 3,000 to 13,000 / mm 3 Neutrophils 1,500 / mm 3 or more Platelets 100,000 / mm 3 or more Total bilirubin 1.5 mg / dL or less AST 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed ALT 100 IU / L or less, provided that it has liver metastasis, up to 5 times the upper limit of the facility reference value is allowed 11) Hospitalization treatment and outpatient treatment are not limited 12) Regarding the participation of this study, consent from the person in writing is obtained.
Exclusion criteria
Exclusion criteria: 1) Patients receiving transfusions, blood products and hematopoietic factor preparations such as G-CSF within 14 days before registration 2) Cases with infections or diseases requiring systemic administration of antibiotics, antifungal agents 3) Cases with complications as shown below Control poor hypertension, diabetes Severe lung disease (interstitial pneumonia, pulmonary fibrosis, advanced emphysema, etc.) Liver failure Gastrointestinal bleeding that requires treatment 4) Patients with marked electrocardiogram abnormality or cases with clinically problematic heart disease Cases with congestive heart failure, symptomatic coronary artery disease, poorly controlled arrhythmia, a history of myocardial infarction that developed within the last 12 months, etc 5) Cases with psychiatric disorder judged by the investigator or test sharing doctor to have acquired consent or adversely affect test performance Control malfunctioning epileptic seizures, central nervous system disorders, etc. 6) Cases with moderate or more ascites (above the pelvic cavity) or with large pleural effusions 7) Cases with brain metastasis or suspected brain metastasis from clinical symptoms 8) Cases with extensive bone metastases 9) Cases with active duplicated cancers 10) HIV antibody positive cases 11) Patients who received treatment with another study drug within 4 weeks before registration of this study or participate in other clinical trials (incidental study of this study "Esophageal cancer chemical radiation by genetic analysis Clinical research on susceptibility of therapy and prediction of side effects "excluding) 12) Cases judged unsuitable as subjects of the examination by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| phase 1 part: DLT expression rate phase 2 part: Response rate | — |
Countries
Japan
Contacts
Public ContactKazumi Hayashi
The Jikei University school of medicine Department of Hematology and Oncology
Outcome results
None listed