Finding studies
Finding studies
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Lead
Wake Forest University Health Sciences
With
OBJECTIVES: * 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 progression. 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.
Age
18–120
Sex
ALL
Healthy volunteers
Not accepted
