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

NCT00915850 | Unknown Phase 1 DMC

• 1 other identifier: WMU-EC01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

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

  1 month

Secondary Outcomes (5)

• To determine the recommended phase II dose of docetaxel (Phase I)

  1 month

• To determine the clinical effectiveness in the patients with measurable disease (Phase I)

  1 month

• To analyze the toxicity (Phase II)

  1 month

• Time to progression (Phase II)

  5 years

• median survival time (Phase II)

  5 years

Study Arms (1)

Anticancer drug

EXPERIMENTAL

docetaxel, cisplatin and 5-FU

Drug: DCF

Interventions

DCF DRUG

docetaxel, Cisplatin and 5-FU

Also known as: docetaxel+Cisplatin+5-FU

Anticancer drug

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• locally advanced or metastatic esophageal cancer precluding curative surgical resection and recurrent esophageal cancer measurable disease by CT scan
• ECOG performance status 0-1
• 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
• /mm3 \< WBC \< 12000/mm3
• /mm3 \< granulocyte count
• gm/dl \< hemoglobin
• Platelet count \> 100000/mm3
• Aspartate transaminase \< 150 IU/L
• Alanine transaminase \< 150 IU/L

You may not qualify if:

• 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

Sponsors & Collaborators

• Wakayama Medical University: lead

Study Sites (1)

Wakayama Medical University

Wakayama, Wakayama, 641-8510, Japan

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Makoto Iwahashi, M.D.

  Second Department of Surgery, Wakayama Medical University

  STUDY DIRECTOR

Central Study Contacts

Makoto Iwahashi, MD

CONTACT

81-73-441-0613; makoto@wakayama-med.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 8, 2009
• Study Start: August 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2015
• Last Updated: September 9, 2010

Record last verified: 2010-09

Locations

JP (1)