Phase I Trial of Induction Paraplatin® and Xeloda® Followed by Concurrent Paraplatin and Xeloda With Intensity Modulated Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- Determine the maximum tolerated dose (MTD) of capecitabine when administered with
carboplatin as induction chemotherapy in patients with stage III-IVB squamous cell
carcinoma of the head and neck.
- Determine the MTD of capecitabine when administered with concurrent carboplatin and
intensity-modulated radiotherapy in these patients.
- Determine the toxicity of this regimen in these patients.
- Determine, preliminarily, tumor response in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a dose-escalation study of capecitabine.
- Induction chemotherapy: Patients receive carboplatin IV on days 1, 8, 15, 22, 29, and
36 and oral capecitabine twice daily on days 1-14 and 22-35.
- Concurrent chemoradiotherapy: Beginning 2 weeks after completion of induction
chemotherapy, patients receive carboplatin and capecitabine as in induction
chemotherapy. Patients also undergo intensity-modulated radiotherapy (IMRT) once daily
on days 1-5, 8-12, 15-19, 22-26, and 29-33 and non-IMRT boost once daily on days 36-40
Treatment continues in the absence of disease progression or unacceptable toxicity.
Within 4-8 weeks after completion of concurrent chemoradiotherapy, patients who achieve a
clinical complete response or who are medically operable with resectable persistent or
recurrent disease undergo neck dissection (salvage surgery).
Cohorts of 3-6 patients receive escalating doses of capecitabine (during both induction
chemotherapy and concurrent chemoradiotherapy) until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose preceding that which 2 of 3 or 2 of 6 patients
experience dose-limiting toxicity.
Quality of life is assessed at baseline, after completion of induction chemotherapy, and
then at 1 week and 3, 6, and 12 months after completion of concurrent chemoradiotherapy.
After completion of study therapy, patients are followed monthly for 3 months and then every
3 months for 1 year.
PROJECTED ACCRUAL: Approximately 6-48 patients will be accrued for this study.
Primary Purpose: Treatment
Christopher Y. Thomas, MD
University of Virginia
United States: Federal Government
|University of Virginia Cancer Center at UV Health System||Charlottesville, Virginia 22908|