Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with docetaxel and radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with gefitinib and radiation therapy in treating patients with stage III non-small cell lung cancer.
Other: laboratory biomarker analysis
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation [ Time Frame: baseline to 2 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2003|
|Study Completion Date:||August 2010|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310154
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1082|
|Study Chair:||Arthur William Blackstock, MD||Comprehensive Cancer Center of Wake Forest University|
|Principal Investigator:||Antonius A. Miller, MD||Comprehensive Cancer Center of Wake Forest University|