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Trial Title:
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
NCT ID:
NCT00915850
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Cisplatin
Docetaxel
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
DCF
Description:
docetaxel, Cisplatin and 5-FU
Arm group label:
Anticancer drug
Other name:
docetaxel+Cisplatin+5-FU
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:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Wakayama Medical University
Address:
City:
Wakayama
Zip:
641-8510
Country:
Japan
Status:
Recruiting
Contact:
Last name:
Makoto Iwahashi, MD
Phone:
81-73-441-0613
Email:
makato@wakayama-med.ac.jp
Start date:
August 2007
Completion date:
August 2015
Lead sponsor:
Agency:
Wakayama Medical University
Agency class:
Other
Source:
Wakayama Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00915850
