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Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: DCF
Type: Drug
Overall Status
Recruiting
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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
- 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
Location
Wakayama Medical University
Wakayama, Japan
Status: Recruiting
Contact: Makoto Iwahashi, MD - 81-73-441-0613 - makato@wakayama-med.ac.jp
Start Date
August 2007
Completion Date
August 2015
Sponsors
Wakayama Medical University
Source
Wakayama Medical University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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