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

Esophageal Cancer Clinical Trial

Official title:

Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00915850
• Other study ID #: WMU-EC01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: June 5, 2009
• Last updated: September 8, 2010
• Start date: August 2007
• Est. completion date: August 2015

Study information

• Verified date: September 2010
• Source: Wakayama Medical University
• Contact: Makoto Iwahashi, MD
• Phone: 81-73-441-0613
• Email: makoto[@]wakayama-med.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Description:

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: August 2015
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Drug:
• DCF
docetaxel, Cisplatin and 5-FU

Locations

Country	Name	City	State
Japan	Wakayama Medical University	Wakayama

Sponsors (1)

Lead Sponsor	Collaborator
Wakayama Medical University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST)		1 month	Yes
Secondary	To determine the recommended phase II dose of docetaxel (Phase I)		1 month	Yes
Secondary	To determine the clinical effectiveness in the patients with measurable disease (Phase I)		1 month	Yes
Secondary	To analyze the toxicity (Phase II)		1 month	No
Secondary	Time to progression (Phase II)		5 years	No
Secondary	median survival time (Phase II)		5 years	Yes