Trials / Unknown
UnknownNCT00915850
Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- Wakayama Medical University · Academic / Other
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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
\<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 fluorouracil (600mg/m2,day1-5) (DCF) in unresectable advanced esophageal cancer. Secondary Objective: To observe the efficacy of this regimen in these patients. \<Phase II\> 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DCF | docetaxel, Cisplatin and 5-FU |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2010-08-01
- Completion
- 2015-08-01
- First posted
- 2009-06-08
- Last updated
- 2010-09-09
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT00915850. Inclusion in this directory is not an endorsement.