This phase I/II study is being conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (DCF) in unresectable advanced esophageal cancer. The usefulness of the this regimen is evaluated by RECIST, time to progression and median survival time.
\<Phase I\> 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. \<Phase II\> 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
docetaxel, Cisplatin and 5-FU
Wakayama Medical University
Wakayama, Wakayama, Japan
RECRUITINGSafety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
Time frame: 1 month
To determine the recommended phase II dose of docetaxel (Phase I)
Time frame: 1 month
To determine the clinical effectiveness in the patients with measurable disease (Phase I)
Time frame: 1 month
To analyze the toxicity (Phase II)
Time frame: 1 month
Time to progression (Phase II)
Time frame: 5 years
median survival time (Phase II)
Time frame: 5 years
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