Phase II trial of docetaxel in advanced or metastatic endometrial cancer: a Japanese Cooperative Study

Br J Cancer. 2005 Oct 31;93(9):999-1004. doi: 10.1038/sj.bjc.6602817.

Abstract

The purpose of this study was to determine whether docetaxel has antitumour activity in patients with advanced or recurrent endometrial carcinoma. Chemotherapy-naïve or previously treated patients (one regimen) with histopathologically documented endometrial carcinoma and Eastern Cooperative Oncology Group performance status </=2 entered the study. Docetaxel 70 mg m(-2) was administered intravenously on day 1 of a 3-week cycle up to a maximum of six cycles. If patients responded well to docetaxel, additional cycles were administered until progressive disease or unacceptable toxicity occurred. Of 33 patients with a median age of 59 years (range, 39-74 years) who entered the study, 14 patients (42%) had received one prior chemotherapy regimen. In all, 32 patients were evaluable for efficacy, yielding an overall response rate of 31% (95% confidence interval, 16.1-50.0%); complete response and partial response (PR) were 3 and 28%, respectively. Of 13 pretreated patients, three (23%) had a PR. The median duration of response was 1.8 months. The median time to progression was 3.9 months. The predominant toxicity was grade 3-4 neutropenia, occurring in 94% of the patients, although febrile neutropenia arose in 9% of the patients. Oedema was mild and infrequent. Docetaxel has antitumour activity in patients with advanced or recurrent endometrial carcinoma, including those previously treated with chemotherapy; however, the effect was transient and accompanied by pronounced neutropenia in most patients.

Publication types

  • Clinical Trial, Phase II
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / mortality
  • Adenocarcinoma / secondary*
  • Adenocarcinoma, Papillary / drug therapy
  • Adenocarcinoma, Papillary / mortality
  • Adenocarcinoma, Papillary / secondary
  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic / therapeutic use*
  • Carcinoma, Squamous Cell / drug therapy
  • Carcinoma, Squamous Cell / mortality
  • Carcinoma, Squamous Cell / secondary
  • Cystadenocarcinoma, Serous / drug therapy
  • Cystadenocarcinoma, Serous / mortality
  • Cystadenocarcinoma, Serous / secondary
  • Docetaxel
  • Endometrial Neoplasms / drug therapy*
  • Endometrial Neoplasms / mortality
  • Endometrial Neoplasms / pathology
  • Female
  • Humans
  • Japan
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Salvage Therapy*
  • Survival Rate
  • Taxoids / therapeutic use*

Substances

  • Antineoplastic Agents, Phytogenic
  • Taxoids
  • Docetaxel