Background: To determine a new taxane plus platinum treatment regimen for squamous cell carcinoma of the uterine cervix (CSCC), a phase I feasibility study of docetaxel (DTX) plus nedaplatin (CDGP) combination therapy was conducted.
Patients and methods: Twenty consecutive patients were enrolled into the study. The starting dose of DTX/CDGP was 60 mg/m2 / 80 mg/m2, every 4 weeks for at least three courses and the dose was escalated to 70 mg/m2 / 100 mg/m2. DTX 60 mg/m2 / CDGP 100 mg/m2 was also evaluated as an extra dose level.
Results: Dose-limiting toxicity was granulocytopenia and the maximum tolerated dose was determined as 70 mg/m2 / 100 mg/m2. All 20 patients had measurable disease and a partial response was achieved in 8 (40.0%) patients.
Conclusion: DTX/CDGP therapy appears to be a tolerable regimen for cervical squamous cell carcinoma, even in patients previously treated by cisplatin concurrent chemoradiotherapy. The recommended doses of DTX and CDGP were determined to be 60 mg/m2 and 100 mg/m2, respectively.