Gan to kagaku ryoho. Cancer & chemotherapy
-
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.
-
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.
-
Gan To Kagaku Ryoho · Sep 1994
Multicenter Study Clinical Trial Controlled Clinical Trial[Phase I clinical trial of RP 56976 (docetaxel) a new anticancer drug].
A multicenter phase I clinical trial of RP 56976 (docetaxel), a new anticancer drug, was performed with single and repeated doses. Based on the results of phase I clinical trials conducted in the United States and Europe, the starting dose was 10 mg/m2. The dose was subsequently increased to 20, 50, 70 and 90 mg/m2. ⋯ The white blood cell count reached a nadir about 9.5-19.5 days (median) after administration, and took 7-11 days (median) to recover. Other adverse reactions observed were nausea/vomiting anorexia, alopecia, diarrhea, fatigue and fever, which were all acceptable. The results of this trial suggest that a dosage regimen of 60 mg/m2 at 3- to 4 week intervals is appropriate in an early phase II clinical trial.
-
Gan To Kagaku Ryoho · Sep 1994
Clinical Trial Controlled Clinical Trial[The effect of intraperitoneal and intra-aortic chemotherapy for unresectable gastric cancer].
Regional chemotherapy was given 16 unresectable gastric cancer patients. Two types of the chemotherapy, intraperitoneal (IP) and intraaortic (IA) administration, were carried out. The control group was comprised of 17 patients. ⋯ IP showed a significantly longer survival rate than controls (p < 0.001). All but one patient was able to stay at home. Intraperitoneal chemotherapy showed both local and systemic effects in unresectable gastric cancer.
-
Gan To Kagaku Ryoho · Sep 1994
Case Reports[Hepatic arterial infusion therapy in a patient with multiple hepatic metastases from gastric cancer].
A patient with multiple hepatic metastases (H3) from advanced gastric cancer was treated with pre- and post-operative arterial infusion therapy. A Port-A-Cath was cannulated into the gastroduodenal artery after total gastrectomy. ⋯ The patient has been alive for 15 months after the operation without any complaint. Arterial infusion chemotherapy through implantable reservoir is useful for the treatment of unresectable hepatic metastasis without decreasing the quality of life.