Abstract
Objective: This phase I clinical trial for cervical carcinoma had three objectives: to evaluate the toxicity of a concurrent chemoradiation regimen featuring weekly nedaplatin; to determine the recommended dose of nedaplatin for a phase II concurrent chemoradiation trial; and to evaluate the formula for predicting area under the curve data for nedaplatin through pharmacokinetic studies. Patients and methods: Twelve patients with locally advanced squamous cell carcinoma of the uterine cervix were enrolled. Nedaplatin was administered once a week for 6 weeks. The starting dose of nedaplatin was 25 mg/m2/week, with increments of 5 mg/m2/week planned for each dose level. Three cases were enrolled at each of the dose levels. Radiation therapy was delivered with both external beam teletherapy and intracavitary brachytherapy with HDR-RALS. Volunteering patients underwent pharmacokinetics studies during the second course. Results: Nedaplatin at a dose of 25, 30, and 35 mg/m2 was safely administered for three cases at each dose level. At a dose of 40 mg/m2, however, all three cases had Grade 3 neutropenia. Observed area under the curve value and predicted value was closely correlated, with differences between the two area under the curve values within 25%. All 12 cases achieved a clinical complete response, as evaluated with RECIST. Conclusions: Our recommended dose for a phase II trial of concurrent chemoradiation with weekly nedaplatin is 35 mg/m2. The formula can predict unbound concentration of nedaplatin based on area under the curve within 25% error.
Original language | English |
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Pages (from-to) | 36-40 |
Number of pages | 5 |
Journal | Gynecologic Oncology |
Volume | 104 |
Issue number | 1 |
DOIs | |
Publication status | Published - 2007 Jan |
Keywords
- Cervical cancer
- Chemoradiation
- Concurrent
- Nedaplatin
- Pharmacokinetics
ASJC Scopus subject areas
- Oncology
- Obstetrics and Gynaecology