Phase I/II Study of Docetaxel, Cisplatin and 5-fluorouracil(TPF) as Chemotherapy in Pre-treated Patients With Metastatic Esophageal Cancer.
Patients with pre-treated 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 30 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Masahiro Asaka, MD, PhD
Hokkaido Gastrointestinal Cancer Study Group
Japan: Ministry of Health, Labor and Welfare