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Sponsored by: |
Barbara Ann Karmanos Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00268255 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. Gefitinib may make tumor cells more sensitive to radiation therapy. Giving gefitinib together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of radiation therapy when given together with gefitinib and to see how well they work in treating patients with inoperable stage I or stage II non-small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Non-Small Cell Lung Cancer |
Drug: gefitinib Procedure: adjuvant therapy Procedure: enzyme inhibitor therapy Procedure: neoadjuvant therapy Procedure: protein tyrosine kinase inhibitor therapy Procedure: radiation therapy Procedure: radiosensitization |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I/II Study of Induction Gefitinib and Concurrent Radiotherapy in Patients With Previously Untreated, Medically Inoperable Stage I or II Non-Small Cell Lung Cancer |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter, dose-escalation study of radiotherapy.
Cohorts of 6-10 patients receive escalating doses of radiotherapy until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience acute dose-limiting toxicity.
After completion of study treatment, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Other
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201 |
Study Chair: | Andrew T. Turrisi, MD | Barbara Ann Karmanos Cancer Institute |
Study ID Numbers: | CDR0000447160, WSU-D-2820, WSU-HIC-100304M1F, ZENECA-1839US/0258 |
Study First Received: | December 20, 2005 |
Last Updated: | December 4, 2006 |
ClinicalTrials.gov Identifier: | NCT00268255 History of Changes |
Health Authority: | United States: Federal Government |
stage I non-small cell lung cancer stage II 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 Adjuvants, Immunologic Protein Kinase Inhibitors Carcinoma 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 |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |