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Sponsors and Collaborators: |
Wake Forest University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00310154 |
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.
Condition | Intervention | Phase |
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Lung Cancer |
Drug: docetaxel Drug: gefitinib Other: laboratory biomarker analysis Radiation: radiation therapy |
Phase I |
Study Type: | Interventional |
Study Design: | 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 |
Estimated Enrollment: | 45 |
Study Start Date: | November 2003 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of docetaxel.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
United States, North Carolina | |
Wake Forest University Comprehensive Cancer Center | |
Winston-Salem, North Carolina, United States, 27157-1082 |
Study Chair: | Arthur William Blackstock, MD | Wake Forest University |
Investigator: | Antonius A. Miller, MD | Wake Forest University |
Study ID Numbers: | CDR0000466391, CCCWFU-62202, ZENECA-IRUSIRES0043, CCCWFU-BG03-310 |
Study First Received: | March 29, 2006 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00310154 History of Changes |
Health Authority: | United States: Federal Government |
stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer adenosquamous cell lung cancer bronchoalveolar cell lung cancer |
large cell lung cancer squamous cell lung cancer adenocarcinoma of the lung |
Thoracic Neoplasms Adenocarcinoma, Bronchiolo-Alveolar Protein Kinase Inhibitors Carcinoma Docetaxel Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Non-small Cell Lung Cancer Adenocarcinoma of Lung Adenocarcinoma Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma Docetaxel |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |