5121 Background: The antitumor activity and safety of paclitaxel monotherapy in patients (pts) with endometrial cancer still remain to be clarified. Methods: Eligibility criteria included: advanced or recurrent histopathologically proven endometrial adenocarcinoma with measurable lesion(s), age between 20 and 75, ECOG PS 2 or less, adequate organ functions, and written informed consent. No more than one regimen of prior chemotherapy was allowed. Pts received paclitaxel 210 mg/m2 by 3-hour infusion every 21 days. Results: Twenty-three pts were enrolled in the study. Pts characteristics include: endometrioid adenocarcinoma (15), adenoacanthoma (2), serous adenocarcinoma (2), clear cell adenocarcinoma (2), adenosquamous carcinoma (1) and mixed adenocarcinoma (1), Stage III/Stage IV/Recurrent = 2/4/17, PS 0/1/2 = 14/7/2. Thirteen pts had received prior chemotherapy. A total of 96 cycles of paclitaxel were administered, with a median of 4 cycles (range, 1–8). There were 7 PRs (30.4%, 95%CI: 13 - 53%), 10 NCs, 5 PDs and 1 NE. Median duration of response was 130 days (100–245 days) in 7 PR pts. Adverse reactions (grade 3, 4) included febrile neutropenia and constipation (8.7%, 2/23). Laboratory test abnormalities (grade 3,4) included neutropenia (78.3%, 18/23), leucopenia (47.8%, 11/23), anemia (13.0%, 3/23), decreased potassium (8.7%, 2/23), and decreased sodium (4.3%, 1/23). All adverse reactions were successfully managed by prolonging treatment interval, dose reduction, interrupting administration, discontinuation, and/or administration of G-CSF. Four pts discontinued treatment due to toxicity. Conclusions: The results suggest that three-hour intravenous infusion of paclitaxel 210 mg/m2 is well-tolerated and active therapy for advanced or recurrent endometrial cancer, and is worthy of further study in combination with carboplatin. No significant financial relationships to disclose.