A Phase 1 interventional study of docetaxel and gefitinib in Lung Cancer, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by Wake Forest University Health Sciences · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
OUTLINE: This is a dose-escalation study of docetaxel.
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.
7,333 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including any of the following:
Stage IIIA/B disease
Tumors adjacent to a vertebral body allowed
Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in the radiation boost field in accordance with the homogeneity criteria
Pleural effusion allowed if it is transudate, cytologically negative, and non-bloody AND tumor can be encompassed within a reasonable field of radiotherapy
Measurable disease, defined as lesions that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
No nonmeasurable disease, including any of the following:
PATIENT CHARACTERISTICS:
Meets 1 of the following criteria:
No other currently active malignancy except nonmelanoma skin cancers
PRIOR CONCURRENT THERAPY:
No other concurrent hormonal therapy or chemotherapy except for the following:
To determine the feasability of daily ZD1839 delivered with concurrent 3-dimensional planned thoracic radiation
Time frame: baseline to 2 months
The record gives a start of Nov 2003, a primary completion of Jul 2007 and a completion of Aug 2010. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Docetaxel · Gefitinib
Wake Forest University Health Sciences →