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

This study is currently recruiting participants. (see Contacts and Locations)
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

June 5, 2009
September 8, 2010
August 2007
August 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00915850 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

<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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Esophageal Cancer
Drug: DCF
docetaxel, Cisplatin and 5-FU
Other Name: docetaxel+Cisplatin+5-FU
Experimental: Anticancer drug
docetaxel, cisplatin and 5-FU
Intervention: Drug: DCF
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32
August 2015
August 2010   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Makoto Iwahashi, MD 81-73-441-0613 makoto@wakayama-med.ac.jp
Japan
 
NCT00915850
WMU-EC01
Yes
Makoto Iwahasi, Wakayama Medical University
Wakayama Medical University
Not Provided
Study Director: Makoto Iwahashi, M.D. Second Department of Surgery, Wakayama Medical University
Wakayama Medical University
September 2010

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