[An early phase II clinical study of RP56976 (docetaxel) in patients with cancer of the gastrointestinal tract].

An early phase II clinical study of RP56976 (docetaxel), a new semisynthetic agent, was conducted in patients with apparatus digestorius cancer. Two or more intravenous doses of 60 mg/m2 were administered with dose-free intervals of 3-4 weeks. Of the 44 patients enrolled, 32 patients (15 patients with gastric cancer, 16 patients with colon cancer, and 1 patient with pancreatic cancer) completed the scheduled course of treatment. For antitumor efficacy in the 15 patients with gastric cancer that completed the study, 3 showed a partial response (PR)(20.0%). Of the 16 patients with colon cancer that completed the study, 1 showed a partial response (PR)(6.3%). No efficacy was noted in the patient with pancreatic cancer. All three patients with gastric cancer showing a partial response (PR) to docetaxel had displayed no response to previous chemotherapy. Evaluation was made for the primary gastric lesion and metastatic lesions in cervical lymph nodes and liver. The most frequent adverse reactions included leukopenia (100%) and neutropenia (97.2%) and subjective/objective adverse reactions included alopecia (80.6%), anorexia (72.2%), fatigue (52.8%), fever (47.2%) nausea/vomiting (47.2%), and diarrhea (38.9%). Leukopenia was of Grade III or more in 75.0% of the patients and neutropenia was of Grade III or more in 91.7%. All other adverse reactions were acceptable. The results suggest that docetaxel is an effective anticancer agent for gastric cancer.