Phase I/II Study of Biweekly Administration Regimen of Paclitaxel Combined With CPT-11 in Patients With Second Line Chemotherapy of Inoperable or Recurrent Gastric Cancer(GC).
Patients with pre-treated measurable metastatic gastric cancer were included in this trial.
Patients received this combination chemotherapy repeated every 28 days until progression
disease. Starting dose (dose level 1) were CPT-11 80 mg/m2 on day 1 and 15, Paclitaxel 60
mg/m2 on day 1 and 15. DLT was defined as follows (according to NCI-CTC version 2.0); Grade
4 neutropenia, thrombocytopenia(≥25000), Grade 3 neutropenia accompanied fever (>38℃) , and
Grade 3 non-hematological toxicity (except for nausea, vomit, appetite loss , general
fatigue, alopecia). 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