Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
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|ClinicalTrials.gov Identifier: NCT00209690|
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-FU 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 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||April 2010|
X mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: Docetaxel
800 mg/m2, CIV (conti.in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: 5-Fluorouracil
15 mg/m2, IV (in the vein) on day 1~4 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Other Name: Cisplatin,CDDP
- 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: one year ]
- Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: one year ]
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): NCT00209690
|・ Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)|
|Sapporo, Hokkaido, Japan, 060-8638|
|Study Chair:||Masahiro Asaka, MD, PhD||Hokkaido Gastrointestinal Cancer Study Group|