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Gynecol Oncol. 2009 May;113(2):195-9. doi: 10.1016/j.ygyno.2008.12.033. Epub 2009 Feb 28.

A phase I study of docetaxel as a radio-sensitizer for locally advanced squamous cell cervical cancer.

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  • 1Department of Reproductive Medicine, Division of Gynecologic Oncology, Moores UCSD Cancer Center, La Jolla, CA 92093-0987, USA. E1alvarez@ucsd.edu

Abstract

OBJECTIVES:

This study was designed to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of weekly docetaxel with concurrent radiotherapy (RT) for the primary treatment of locally advanced squamous cell carcinoma of the cervix.

METHODS:

Eligible patients included those with locally advanced squamous cell cervical cancer without para-aortic lymph node involvement. Docetaxel dose levels were 20 mg/m(2), 30 mg/m(2) and 40 mg/m(2) given intravenously weekly for 6 cycles. Three patients were to be treated at each dose level and 6 to receive the MTD.

RESULTS:

Fifteen patients completed 4-6 cycles of chemotherapy. One of three patients experienced 2 delayed grade 3 severe adverse events (SAE) at the 20 mg/m(2) dose level consisting of colonic and ureteral obstruction. At the 30 mg/m(2) dose level, 1/4 patients had a probable treatment-related celiotomy due to obstipation and a necrotic tumor. Of the 8 patients treated at the 40 mg/m(2) dose level, 1 experienced grade 3 pneumonitis, likely treatment related. Overall, 10/15 (67%) experienced grade 1 or 2 diarrhea, 6 had grade 2 hematologic toxicity, and 2 had grade 2 hypersensitivity. 10 of 16 patients (67%) had no evidence of disease with follow-up ranging from 10-33 months (average 23 months).

CONCLUSIONS:

The recommended phase II dose of docetaxel administered weekly with concurrent radiotherapy for locally advanced squamous cell carcinoma of the cervix is 40 mg/m(2).

PMID:
19251309
[PubMed - indexed for MEDLINE]
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