Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
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.
To observe the efficacy of this regimen in these patients.
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.
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.
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)
Makoto Iwahashi, M.D.
Second Department of Surgery, Wakayama Medical University
Japan: Ministry of Health, Labor and Welfare