Trial of Docetaxel, Cisplatin, Fluorouracil (5-FU) for Unresectable Advanced Esophageal Squamous Cell Carcinoma (ESCC)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Trial of Combination Chemotherapy With Docetaxel, Cisplatin and 5-FU for Unresectable Advanced Esophageal Cancer.|
- Safety (Phase I: toxicities as assessed by NCI CTCAE version3) and efficacy (Phase II: Feasibility as evaluated by RECIST) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- To determine the recommended phase II dose of docetaxel (Phase I) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- To determine the clinical effectiveness in the patients with measurable disease (Phase I) [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
- To analyze the toxicity (Phase II) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Time to progression (Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- median survival time (Phase II) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Experimental: Anticancer drug
docetaxel, cisplatin and 5-FU
docetaxel, Cisplatin and 5-FU
Other Name: docetaxel+Cisplatin+5-FU
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.
To observe the efficacy of this regimen in these patients.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00915850
|Contact: Makoto Iwahashi, MDfirstname.lastname@example.org|
|Wakayama Medical University||Recruiting|
|Wakayama, Japan, 641-8510|
|Contact: Makoto Iwahashi, MD 81-73-441-0613 email@example.com|
|Study Director:||Makoto Iwahashi, M.D.||Second Department of Surgery, Wakayama Medical University|