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

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

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.

Study Overview

• Status: Unknown
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: DCF

Detailed Description

<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
• Enrollment (Anticipated): 32
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Makoto Iwahashi, MD; Phone Number: 81-73-441-0613; Email: makoto@wakayama-med.ac.jp

Study Locations

• Japan
  • Wakayama, Japan, 641-8510
    • Recruiting
    • Wakayama Medical University
    • Contact: Makoto Iwahashi, MD; Phone Number: 81-73-441-0613; Email: makato@wakayama-med.ac.jp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anticancer drug; docetaxel, cisplatin and 5-FU	Drug: DCF; docetaxel, Cisplatin and 5-FU; Other Names: docetaxel+Cisplatin+5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Wakayama Medical University
• Investigators: Study Director: Makoto Iwahashi, M.D., Second Department of Surgery, Wakayama Medical University

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): August 1, 2015

Study Registration Dates

• First Submitted: June 5, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (Estimate): June 8, 2009

Study Record Updates

• Last Update Posted (Estimate): September 9, 2010
• Last Update Submitted That Met QC Criteria: September 8, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Cisplatin
• Other Study ID Numbers: WMU-EC01