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

Primary Purpose

Esophageal Cancer

Status
Unknown status
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
DCF
Sponsored by
Wakayama Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wakayama Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anticancer drug

Arm Description

docetaxel, cisplatin and 5-FU

Outcomes

Primary Outcome Measures

Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)

Secondary Outcome Measures

To determine the recommended phase II dose of docetaxel (Phase I)
To determine the clinical effectiveness in the patients with measurable disease (Phase I)
To analyze the toxicity (Phase II)
Time to progression (Phase II)
median survival time (Phase II)

Full Information

First Posted
June 5, 2009
Last Updated
September 8, 2010
Sponsor
Wakayama Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT00915850
Brief Title
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Official Title
Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Wakayama Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
<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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anticancer drug
Arm Type
Experimental
Arm Description
docetaxel, cisplatin and 5-FU
Intervention Type
Drug
Intervention Name(s)
DCF
Other Intervention Name(s)
docetaxel+Cisplatin+5-FU
Intervention Description
docetaxel, Cisplatin and 5-FU
Primary Outcome Measure Information:
Title
Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
To determine the recommended phase II dose of docetaxel (Phase I)
Time Frame
1 month
Title
To determine the clinical effectiveness in the patients with measurable disease (Phase I)
Time Frame
1 month
Title
To analyze the toxicity (Phase II)
Time Frame
1 month
Title
Time to progression (Phase II)
Time Frame
5 years
Title
median survival time (Phase II)
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Makoto Iwahashi, MD
Phone
81-73-441-0613
Email
makoto@wakayama-med.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Makoto Iwahashi, M.D.
Organizational Affiliation
Second Department of Surgery, Wakayama Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Wakayama Medical University
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Makoto Iwahashi, MD
Phone
81-73-441-0613
Email
makato@wakayama-med.ac.jp

12. IPD Sharing Statement

Learn more about this trial

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

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