esophageal squamous cell carcinoma
Conditions
Interventions
Nedaplatin Docetaxel level0: 70mg/m2 50mg/m2 level1: 70mg/m2 60mg/m2 level2: 80mg/m2 60mg/m2 level3: 90mg/m2 60mg/m2 level4: 90mg/m2 70mg/m2 Repeat every 4 weeks
Sponsors
University of Toyama
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with metastatic or recurrent esophageal SCC who had previously been treated with cisplatin plus 5-fluorouracil were enrolled in the study. The eligibility criteria were as follows: (a) histologically confirmed esophageal SCC; (b) age 20-75 years, (c) Eastern Clinical Oncology Group performance status score 0,1,2; (d) life expectancy of at least 8 weeks; (e) provision of written informed consent; (f) adequate bone marrow function (white blood cell count >=3000/mm3, platelet count >=100 000/mm3); (g) adequate hepatic function (total serum bilirubin level <=1.5 mg/dl, aspartate aminotransferase and alanine aminotransferase levels less than or equal to twice the upper limit of the normal ranges); and (h) adequate renal function (serum creatinine <=1.5 mg/dl).
Exclusion criteria
Exclusion criteria: Exclusion criteria included concomitant uncontrolled diabetes mellitus, hypertension, severe heart disease, active infection, active double cancer, massive ascites, massive pleural effusion, massive pericardial effusion, active gastrointestinal tract bleeding, possible pregnancy, brain metastases with any symptoms, severe psychological disease, and tracheoesophageal fistula formation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum Tolerated Dose, Recommended dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, Progression free survival, Overall survival | — |
Countries
Japan
Contacts
Public ContactShinya Kajiura
Universtiy of Toyama Department of Gastroenterology
Outcome results
None listed