Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Oct 1994
Multicenter Study Clinical Trial[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. ⋯ 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.
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Gan To Kagaku Ryoho · Oct 1994
Multicenter Study Clinical Trial[Phase II clinical study of RP56976 (docetaxel) in patients with carcinoma ovarii or carcinoma colli uteri].
An early phase II clinical study of RP56976 (docetaxel), a new semisynthetic agent, in patients with carcinoma ovarii or carcinoma colli uteri was undertaken by a cooperative study group of 23 institutes. Docetaxel was administered at an initial intravenous dose of 60 mg/m2 with dose-free intervals of 3-4 weeks, and its efficacy and safety were evaluated. Of the 47 patients with carcinoma ovarii enrolled, 44 patients were eligible and 36 patients completed the scheduled course of treatment. ⋯ The overall response rate was 2.8% (1/36). Of patients with carcinoma colli uteri, 7 patients showed no changes (NC) (1 patient showed minor response (MR)), 8 patients had progressive disease (PD). Major adverse reactions included 64/65 (98.5%) leukopenia, 56/59 (94.9%) neutropenia, 40/60 (61.5%) decrease of hemoglobin, 12/64 (18.8%) thrombocytopenia, 30/65 (46.2%) anorexia, 23/65 (35.4%) nausea/vomiting, 37/65 (56.9%) alopecia, and 26/65 (40.0%) fatigue, all of which were mild.
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Gan To Kagaku Ryoho · Oct 1994
Multicenter Study Clinical Trial[An early phase II clinical study of RP56976 (docetaxel) in patients with breast cancer].
An early phase II clinical study of RP56976 (docetaxel), a new anticancer agent of plant origin, was conducted in patients with breast cancer at 20 Japanese collaborative institutions. Docetaxel was administered at two or more doses of 60 mg/m2 by intravenous infusion with dose-free intervals of 3-4 weeks, and the efficacy and safety was evaluated. Of the 51 patients enrolled, 50 patients completed the scheduled course of treatment. ⋯ Grade 3 or more severe leukopenia and neutropenia developed in 43 patients (84.3%) and 48 patients (94.1%), respectively. Other adverse reactions which occurred in a Grade 3 or more severe form included nausea/vomiting (1 patient), anorexia (5 patients), diarrhea (4 patients), fatigue (2 patients), and alopecia (20 patients). Except for alopecia, most adverse reactions were generally transient and reversible without any specific treatment.