Gan to kagaku ryoho. Cancer & chemotherapy
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Gan To Kagaku Ryoho · Nov 1994
Multicenter Study Clinical Trial[Early phase II clinical study of RP56976 (docetaxel) in patients with primary pulmonary cancer. Docetaxel Cooperative Study Group for Lung Cancer].
An early phase II clinical study of RP56976 (Docetaxel), a new anticancer agent of plant origin, was conducted in patients with primary pulmonary cancer as a multicentered study involving 28 Japanese institutions. Docetaxel was administered at an intravenous dose of 60 mg/m2 based on the results of a phase I clinical study, and efficacy and safety were examined. Of the 65 patients enrolled, 57 patients were evaluated to have completed the scheduled course of treatment by the Evaluation Committee. ⋯ Hematological adverse reactions included leukopenia and neutropenia of Grade III or more as specified in the Adverse Event Reporting Form proposed by the Japan Society for Cancer Therapy in 53.3% (32/60) and 78.3% (47/60) patients, respectively. Other major adverse reactions included alopecia and anorexia. Neurological symptoms developed at a low frequency and were mild in severity.
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Gan To Kagaku Ryoho · Nov 1994
Multicenter Study Clinical Trial[Late phase II clinical study of RP56976 (docetaxel) in patients with advanced/recurrent breast cancer].
A late phase II clinical study of RP56976 (Docetaxel), a new semisynthetic anticancer agent, was conducted in patients with advanced/recurrent breast cancer. RP56976 (Docetaxel) was in general administered at an intravenous dose of 60 mg/m2 with dose-free intervals of 3-4 weeks. Of the 74 patients enrolled, 64 patients completed the scheduled course of treatment. ⋯ Adverse reactions included nausea/vomiting in 38 patients (57.6%), fatigue in 46 patients (69.7%), anorexia in 46 patients (69.7%), fever in 26 patients (39.4%), and alopecia in 60 patients (90.9%), all of which were tolerable. Abnormal laboratory findings included leukopenia (Grade III or more) in 57 patients (86.4%) and neutropenia (Grade III or more) in 56 patients (86.2%). The results show that RP56976 (Docetaxel) is an excellent agent with high antitumor effect for the treatment of advanced/recurrent breast cancer.
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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
Review[Current status and issues in clinical trials of anticancer agents].
NDA filing and government approval for drug manufacturing marketing rights are processes based on collaboration among the concerned parties; a drug manufacturer (or importer), a medical institution and a government agency. However, quality guidelines are necessary for a scientific, ethical and economically efficient clinical study to be conducted. ⋯ Among them we discuss the following items for revision of the Guidelines and made suggestions and opinions from the manufacturers' point of view: Phase I: Number of institutions for clinical study, determination of MTD and study design. Phase II: Introduction of foreign data, late phase II study for plural numbers of indications at time of NDA filing and evidence of usefulness in concurrent therapy.
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Development of new anticancer drugs is essential to improve the response and survival of cancer patients. Nationally supported organizations have a key role in conducting very experimental expensive and ethical clinical trials. In the U. ⋯ Their team consists of younger physicians, research nurses, data managers, pharmacologists, technicians and the primary investigator under strong leadership. Recently, international harmonization of the U. S., -Europe and Japan is postulated politically, However, we have to recognize that this interrelationship has another meaning, that of "international competition and comparison" with each other in the field of new drug development.