title: [Phase II clinical study of RP56976 (docetaxel) in patients with carcinoma ovarii or carcinoma colli uteri].
abstract: 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. Of the 23 patients with carcinoma colli uteri enrolled, 20 patients were eligible and 15 patients completed the scheduled course of treatment. For antitumor efficacy in patients with carcinoma ovarii, 1 patient showed partial response (PR), 10 showed no changes (NC) (2 showed minor response (MR)), and 25 had progressive disease (PD). 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.
authors.affiliation: Department of Obstetrics & Gynecology, Kinki University School of Medicine.
authors.forename: K
authors.initials: K
authors.lastname: Noda
authors.forename: Y
authors.initials: Y
authors.lastname: Terajima
authors.forename: Y
authors.initials: Y
authors.lastname: Ogita
authors.forename: I
authors.initials: I
authors.lastname: Kono
authors.forename: K
authors.initials: K
authors.lastname: Hirabayashi
authors.forename: M
authors.initials: M
authors.lastname: Yakushiji
authors.forename: T
authors.initials: T
authors.lastname: Taguchi
mesh_terms: D018262:Adenocarcinoma, Clear Cell / Q000188:drug therapy; D000328:Adult; D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D043823:Taxoids; D013921:Thrombocytopenia / Q000139:chemically induced; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel