Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Phase 1 Completed 45 enrolled Wake Forest University Health Sciences National Cancer Institute (NCI) · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2003-11
Primary completion: 2007-07
Completion: 2010-08

Publications

Results Center B, Petty WJ, Ayala D, Hinson WH, Lovato J, Capellari J, Oaks T, Miller AA, Blackstock AW. A phase I study of gefitinib with concurrent dose-escalated weekly docetaxel and conformal three-dimensional thoracic radiation followed by consolidative docetaxel and maintenance gefitinib for patients with stage III non-small cell lung cancer. J Thorac Oncol. 2010 Jan;5(1):69-74. doi: 10.1097/JTO.0b013e3181c59a0e.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Docetaxel	Small molecule	15 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	20 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	25 mg/m2	Intravenous
Subject	Docetaxel	Small molecule	30 mg/m2	Intravenous
Background	Gefitinib	Small molecule	250 mg	Oral

Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer

Summary

Timeline

Publications

Drugs

Indications