Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)

Study Overview
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Brief Summary
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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.

Detailed Description
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<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.

Official Title
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Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.

Conditions
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Esophageal Cancer

Intervention / Treatment
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* Drug: DCF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan ECOG performance status 0-1 20 years and older Patients must have clinically documented unresectable or metastatic esophageal cancer and histologic confirmation of the diagnosis with tumor Tissue from tumor must be available Patients must have measurable disease Patients may have received prior adjuvant chemotherapy; this must have been completed at least 1 month Life expectancy > 3 months Laboratory values as follows 3000/mm3 < WBC < 12000/mm3 1500/mm3 < granulocyte count 8.0 gm/dl < hemoglobin Platelet count > 100000/mm3 Aspartate transaminase < 150 IU/L Alanine transaminase < 150 IU/L Creatinine < 1.5 mg/dl Able and willing to give valid written informed consent Exclusion Criteria: Pregnancy (women of childbearing potential: refusal or inability to use effective means of contraception) Active or uncontrolled infection Prior chemotherapy or radiation therapy within 4 weeks, surgery within 3 weeks or immunotherapy within 1 week Clinically significant heart disease Patients with a history of myocardial infarction within the previous three months Patients with uncontrolled diabetes mellitus or hypertension Presence of clinically apparent central nervous system metastases Patients with any other severe concurrent disease, which in the judgment of the investigator, would make the patient inappropriate for entry into this study Decision of unsuitableness by principal investigator or physician-in-charge

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anticancer drug<br>docetaxel, cisplatin and 5-FU | Drug: DCF<br>* docetaxel, Cisplatin and 5-FU<br>* Other names: docetaxel+Cisplatin+5-FU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the recommended phase II dose of docetaxel (Phase I) |  | 1 month | 
| To determine the clinical effectiveness in the patients with measurable disease (Phase I) |  | 1 month | 
| To analyze the toxicity (Phase II) |  | 1 month | 
| Time to progression (Phase II) |  | 5 years | 
| median survival time (Phase II) |  | 5 years |