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

This study is currently recruiting participants.
Verified September 2010 by Wakayama Medical University
Sponsor:
Information provided by:
Wakayama Medical University
ClinicalTrials.gov Identifier:
NCT00915850
First received: June 5, 2009
Last updated: September 8, 2010
Last verified: September 2010
  Purpose

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915850

Contacts
Contact: Makoto Iwahashi, MD 81-73-441-0613 makoto@wakayama-med.ac.jp

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

No publications provided

Responsible Party: Makoto Iwahasi, Wakayama Medical University
ClinicalTrials.gov 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:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 15, 2014