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Gynecol Oncol. 1996 Aug;62(2):278-81.

A phase II trial of paclitaxel in patients with advanced or recurrent adenocarcinoma of the endometrium: a Gynecologic Oncology Group study.

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  • 1Department of Obstetrics and Gynecology, New England Medical Center, Boston, Massachusetts 02111, USA.

Abstract

OBJECTIVE:

To determine the efficacy and toxicity of paclitaxel in advanced or recurrent adenocarcinoma of the endometrium.

METHODS:

Thirty patients with advanced or recurrent endometrial cancer with measurable disease not previously treated with chemotherapy were treated with paclitaxel, 250 mg/m2, over 24 hr with G-CSF, 5 mcg/kg/day, from Days 2 to 12. The cycle was repeated every 21 days. Patients who had received previous pelvic radiation were treated at an initial paclitaxel dose of 200 mg/m2. Twenty-eight patients were evaluable for response, and 29 patients for toxicity. All patients were Gynecologic Oncology Group performance status 0,1, or 2.

RESULTS:

Complete responses were observed in 4 (14.3%) and partial responses in 6 patients (21.4%) for a response rate of 35.7%. Severe (grade 3 or 4) leukopenia or thrombocytopenia was seen in 18 and 2 patients, respectively. Grade 3 or 4 gastrointestinal toxicity was seen in 5, neurotoxicity in 3, anemia in 2, and cardiac toxicity in 1 patients. Alopecia was reported in 16 patients.

CONCLUSIONS:

This dose and schedule of paclitaxel are active in patients with advanced or recurrent adenocarcinoma of the endometrium and should be considered for inclusion in phase III trials.

PMID:
8751561
DOI:
10.1006/gyno.1996.0227
[PubMed - indexed for MEDLINE]
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