Status:
UNKNOWN
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Lead Sponsor:
Wakayama Medical University
Conditions:
Esophageal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
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-fluoro...
Detailed Description
\<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 fluoroura...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00915850
Start Date
August 1 2007
End Date
August 1 2015
Last Update
September 9 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wakayama Medical University
Wakayama, Wakayama, Japan, 641-8510