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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Wakayama Medical University.
Recruitment status was  Recruiting
Information provided by:
Wakayama Medical University Identifier:
First received: June 5, 2009
Last updated: September 8, 2010
Last verified: September 2010
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.

Condition Intervention Phase
Esophageal Cancer
Drug: DCF
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.

Resource links provided by NLM:

Further study details as provided by Wakayama Medical University:

Primary Outcome Measures:
  • Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To determine the recommended phase II dose of docetaxel (Phase I) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • To determine the clinical effectiveness in the patients with measurable disease (Phase I) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • To analyze the toxicity (Phase II) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Time to progression (Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • median survival time (Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: August 2007
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Anticancer drug
docetaxel, cisplatin and 5-FU
Drug: DCF
docetaxel, Cisplatin and 5-FU
Other Name: docetaxel+Cisplatin+5-FU

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.


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00915850

Contact: Makoto Iwahashi, MD 81-73-441-0613

Wakayama Medical University Recruiting
Wakayama, Japan, 641-8510
Contact: Makoto Iwahashi, MD    81-73-441-0613   
Sponsors and Collaborators
Wakayama Medical University
Study Director: Makoto Iwahashi, M.D. Second Department of Surgery, Wakayama Medical University
  More Information

Responsible Party: Makoto Iwahasi, Wakayama Medical University Identifier: NCT00915850     History of Changes
Other Study ID Numbers: WMU-EC01 
Study First Received: June 5, 2009
Last Updated: September 8, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Esophageal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators processed this record on May 24, 2016