Phase I/II Study of Taxotere,CDDP and 5-FU(TPF) in Pre-treated Pts With Metastatic Esophageal Cancer.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00209716|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 26, 2010
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer||Drug: Taxotere Drug: 5-Fluorouracil Drug: Briplatin||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer.|
|Study Start Date :||December 2003|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||November 2009|
30 mg/m2, IV (in the vein) on day 1 of each 28 day cycle.
Other Name: Docetaxel
800 mg/m2, CIV (CIV.in the vein) on day 1~5 of each 28 day cycle.
Other Name: fluorouracil
15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle.
Other Name: Cisplatin
- Determine the DLT(Dose Limiting Toxicity) and MTD(Maximum Tolerated Dose) in Phase I setting. Determine the clinical response rate with Recommended dose in Phase II setting. [ Time Frame: 1 year ]
- Determine the clinical response rate of patients in Phase I setting. [ Time Frame: 1-year ]
- Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: 2-years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00209716
|・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine)|
|Sapporo, Hokkaido, Japan, 060-8638|
|Study Chair:||Masahiro Asaka, MD, PhD||Hokkaido Gastrointestinal Cancer Study Group|