Elsevier

Gynecologic Oncology

Volume 87, Issue 1, October 2002, Pages 98-103
Gynecologic Oncology

Regular Article
Weekly Carboplatin and Docetaxel for Locally Advanced Primary and Recurrent Cervical Cancer: A Phase I Study

https://doi.org/10.1006/gyno.2002.6786Get rights and content

Abstract

Objective. The aim of this study was to determine the dose-limiting toxicities (DLTs) and maximum tolerated doses (MTDs) of a docetaxel–carboplatin regimen in patients with locally advanced cervical cancer (LACC) or recurrent cervical cancer. The regimen was administered weekly, with a maximum of 12 courses.

Patients and methods. Twenty patients were treated with with a total of 145 cycles of weekly carboplatin and docetaxel. The starting dose of docetaxel was 25 mg/m2 with increments of 5 mg/m2 until a final dose of 35 mg/m2 was reached. Dose–escalation of docetaxel was followed by carboplatin at AUC 2, AUC 2.5, and AUC 3, respectively. Defined dose-limiting toxicities were WHO grade (G) 3 hematotoxicity, G4 mucositis, and G2 neurotoxicity. The response status of the patients was assessed using the common ECOG response criteria.

Results. Two of four patients developed a DLT at dose level 4. Nonhematological toxicity was generally mild, except for ubiquitous complete alopecia. The MTD was reached at docetaxel 35 mg/m2 and carboplatin AUC 2 mg/mL · min. The overall response rate was 65% in the entire group of evaluable patients and 77% in patients with primary LACC, with two cases of pathological complete response.

Conclusion. This dose-dense regimen was well-tolerated and could be administered on an outpatient basis.

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    To whom correspondence and reprint requests should be addressed Department of Gynecology and Obstetrics, University of Düsseldorf, Postfach 10 10 07, 40001 Düsseldorf, Germany. Fax: +49-211-81-18483. E-mail: [email protected].

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