Phase I/II Study of TPF as First-line Chemotherapy in Patients With Metastatic Esophageal Cancer.
A phase I/II study is conducted to determine the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), and efficacy of a combination chemotherapy using docetaxel, cisplatin and 5-fluorouracil (TPF) in untreated patients with metastatic esophageal cancer. The usefulness of the this regimen is evaluated by response rate, median survival time, and progression free survival.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as 1st-line Chemotherapy in Patients With Metastatic Esophageal Cancer.|
- 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 ] [ Designated as safety issue: Yes ]
- Determine the MST(Median Survival Time) and PFS(Progression Free Survival) in Phase II setting. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2003|
|Study Completion Date:||April 2010|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
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: DocetaxelDrug: 5-FU
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-FluorouracilDrug: Briplatin
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
Patients with untreated measurable metastatic esophageal cancer were included in this trial. Patients received this combination chemotherapy repeated every 28 days until progression disease. Starting dose (dose level 1) were docetaxel 50 mg/m2 on day 1, fixed dose intravenously cisplatin (15 mg/m2/day) and continuous infusion 5-FU (800 mg/m2/day) on day 1-4. DLT was defined as follows (according to NCI-CTC version 2.0); Grade 4 neutropenia lasting for more than 4days, Grade 4 anemia and thrombocytopenia, Grade 3 neutropenia accompanied fever (>38℃) , and Grade 3 non-hematological toxicity (except for nausea, appetite loss , general fatigue). Maximal Tolerated Dose (MTD) is determined when the incidence of critical toxicity exceeds 50% at a certain dose level. Response rate will be calculated according to RECIST criteria.
Please refer to this study by its ClinicalTrials.gov identifier: 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|