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

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ClinicalTrials.gov Identifier: NCT00915850
Recruitment Status : Unknown
Verified September 2010 by Wakayama Medical University.
Recruitment status was:  Recruiting
First Posted : June 8, 2009
Last Update Posted : September 9, 2010
Sponsor:
Information provided by:
Wakayama Medical University

Tracking Information
First Submitted Date  ICMJE June 5, 2009
First Posted Date  ICMJE June 8, 2009
Last Update Posted Date September 9, 2010
Study Start Date  ICMJE August 2007
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST) [ Time Frame: 1 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00915850 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2009)
  • To determine the recommended phase II dose of docetaxel (Phase I) [ Time Frame: 1 month ]
  • To determine the clinical effectiveness in the patients with measurable disease (Phase I) [ Time Frame: 1 month ]
  • To analyze the toxicity (Phase II) [ Time Frame: 1 month ]
  • Time to progression (Phase II) [ Time Frame: 5 years ]
  • median survival time (Phase II) [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Official Title  ICMJE Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Cancer
Intervention  ICMJE Drug: DCF
docetaxel, Cisplatin and 5-FU
Other Name: docetaxel+Cisplatin+5-FU
Study Arms  ICMJE Experimental: Anticancer drug
docetaxel, cisplatin and 5-FU
Intervention: Drug: DCF
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 5, 2009)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2015
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00915850
Other Study ID Numbers  ICMJE WMU-EC01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Makoto Iwahasi, Wakayama Medical University
Study Sponsor  ICMJE Wakayama Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Makoto Iwahashi, M.D. Second Department of Surgery, Wakayama Medical University
PRS Account Wakayama Medical University
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP