Phase II trials of docetaxel (Taxotere®) in advanced ovarian cancer - An updated overview Journal Article


Authors: Kaye, S. B.; Piccart, M.; Aapro, M.; Francis, P.; Kavanagh, J.
Article Title: Phase II trials of docetaxel (Taxotere®) in advanced ovarian cancer - An updated overview
Abstract: Docetaxel (Taxotere®) has been studied at a dose of 100mg/m2 i.v. as a one hour infusion every 3 weeks, in four phase II trials in patients with extensively pretreated ovarian cancer. A total of 340 patients were treated, including 256 patients in two separate EORTC (European Organization for Research and Treatment of Cancer) trials and 84 patients in two trials in the U.S.A. All patients had received prior cisplatin or carboplatin therapy and the treatment-free interval was less than 4 months in 155 patients. The overall response rate using conventional UICC criteria was 30% among 315 evaluable cases (95% confidence interval: 24-36%). Among 155 patients whose disease was most refractory (i.e. treatment-free interval was less than 4 months), the overall response rate was 28% (95% confidence interval: 19- 36%). Response duration ranged from 4 to 17 months. Grade IV neutropenia was a common finding and fluid retention was observed. The incidence of febrile neutropenia ranged from 8 to 44% of patients with two deaths (i.e. 0.6% of the total treated) related to neutropenic sepsis. Docetaxel and paclitaxel (Taxol®) have comparable activities in ovarian cancer. Ongoing studies with docetaxel include its use in patients as part of first-line therapy, as well as in patients refractory to paclitaxel. To prevent the development of fluid retention, these now involve the routine use of steroid prophylaxis. It is expected that docetaxel will prove to be an important addition to the drugs available for the treatment of ovarian cancer.
Keywords: adult; controlled study; treatment outcome; aged; middle aged; major clinical study; clinical trial; neutropenia; review; cisplatin; advanced cancer; side effect; paclitaxel; ovarian cancer; ovarian neoplasms; carboplatin; ovary cancer; phase 2 clinical trial; tumor markers, biological; antineoplastic agents, phytogenic; docetaxel; drug hypersensitivity; gastrointestinal toxicity; multicenter study; drug response; taxoids; dermatitis; ca-125 antigen; fluid retention; clinical trials, phase ii; humans; human; female; priority journal
Journal Title: European Journal of Cancer
Volume: 33
Issue: 13
ISSN: 0959-8049
Publisher: Elsevier Inc.  
Date Published: 1997-11-01
Start Page: 2167
End Page: 2170
Language: English
DOI: 10.1016/s0959-8049(97)00363-8
PUBMED: 9470802
PROVIDER: scopus
DOI/URL:
Notes: Review -- Export Date: 17 March 2017 -- Source: Scopus
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  1. Prudence A. Francis
    16 Francis