A Pilot Phase I Dose Escalation Study Of The EGFR Tyrosine Kinase Inhibitor Gefitinib (Iressa) Combined With Paclitaxel (Taxol) And External Beam Radiation Therapy In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck (SCCHN)
- Determine the dose-limiting toxicity, toxicity profile, and maximum tolerated dose
(MTD) of gefitinib and paclitaxel administered with radiotherapy in patients with
advanced or recurrent squamous cell carcinoma of the head and neck.
- Determine the efficacy of this regimen in patients treated at the MTD.
OUTLINE: This is a pilot, dose-escalation study of gefitinib and paclitaxel.
Patients receive oral gefitinib once daily beginning on day 1 and continuing until
completion of radiotherapy. Patients receive paclitaxel IV over 1 hour on days 8, 15, 22,
29, 36, and 43 and undergo radiotherapy once daily on days 8-12, 15-19, 22-26, 29-33, 36-40,
43-47, 50-54, and 57-61. Treatment continues in the absence of disease progression or
Cohorts of 3-6 patients receive escalating doses of gefitinib and paclitaxel until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A cohort of 6 additional
patients receive treatment at the MTD.
Patients are followed monthly for 1 year, every 2 months for 1 year, and then every 3 months
for 3 years.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) as assessed by CTC v. 3.0
Carter Van Waes, MD, PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
United States: Food and Drug Administration
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support||Bethesda, Maryland 20892-1182|
|NCI - Metabolism Branch;MET||Bethesda, Maryland 20892-1547|