ZD-1839 (Iressa®) With Concurrent Docetaxel and Conformal Three Dimensional Thoracic Radiation Followed by Consolidative Docetaxel and ZD-1839 for Patients With Stage III Non Small Cell Lung Cancer: A Phase I Study
- Determine the maximum tolerated dose of docetaxel that can be safely delivered in
combination with gefitinib and a definitive course of 3-D planned thoracic radiotherapy
in patients with stage III non-small cell lung cancer.
OUTLINE: This is a dose-escalation study of docetaxel.
- Chemoradiotherapy: Patients receive concurrent chemoradiotherapy comprising docetaxel
IV over 30 minutes on day 1 and thoracic radiotherapy once daily on days 1-5 in weeks
1-7 in the absence of disease progression or unacceptable toxicity.
- Consolidation chemotherapy: Beginning 2 weeks after the completion of
chemoradiotherapy, patients receive consolidation chemotherapy comprising docetaxel IV
over 60 minutes on days 1 and 22.
- Gefitinib therapy: Patients also receive oral gefitinib once daily beginning at the
start of chemoradiotherapy and continuing for up to 1 year* in the absence of disease
NOTE: *Patients continue to receive gefitinib during the 2-week rest period between
chemoradiotherapy and consolidation chemotherapy.
Cohorts of 3-6 patients receive escalating doses of docetaxel 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.
Tumor tissue is tested to determine correlation between epidermal growth factor receptor
presence and response to treatment.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 45 patients will be accrued in this study.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation
baseline to 2 months
Arthur William Blackstock, MD
Comprehensive Cancer Center of Wake Forest University
United States: Food and Drug Administration
|Wake Forest University Comprehensive Cancer Center||Winston-Salem, North Carolina 27157-1096|