Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
Primary Objective:
To establish the safety of combination chemotherapy comprising docetaxel (escalating doses:
25,30,35,40 mg/m2,day1 and day8), cisplatin (12mg/m2,day1-5), and fluorouracil
(600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objective:
To observe the efficacy of this regimen in these patients.
Primary Objective:
To assess the response rate of combination chemotherapy comprising docetaxel (recommended
dose determined in phase I study,day1 and day8), cisplatin (12 mg/m2, day1-5), and
fluorouracil (600 mg/m2, day1-5) (DCF) in unresectable advanced esophageal cancer.
Secondary Objectives:
To determine the adverse reactions of this regimen in these patients. To determine TTP(Time
to progression) of patients treated with this regimen. To determine MST(Median survival
time) of patients treated with this regimen.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
1 month
Yes
Makoto Iwahashi, M.D.
Study Director
Second Department of Surgery, Wakayama Medical University
Japan: Ministry of Health, Labor and Welfare
WMU-EC01
NCT00915850
August 2007
August 2015
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