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| Sponsors and Collaborators: |
Thomas Jefferson University AstraZeneca |
|---|---|
| Information provided by: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00328562 |
Purpose
The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small-Cell Lung Carcinoma (NSCLC) |
Drug: ZD1839 (Iressa) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase I Study of ZD1839 (Iressa) {IND#66,497} and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non Small Cell Lung Cancer |
| Estimated Enrollment: | 18 |
| Study Start Date: | December 2003 |
| Estimated Study Completion Date: | December 2008 |
To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non–small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method.
The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.
To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Maria Werner-Wasik, MD | 215-955-6705 | maria.werner-wasik@mail.tju.edu |
| Contact: Gayle Mallon, CCRP | 215-955-8619 | gayle.mallon@mail.tju.edu |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: Maria Werner-Wasik, MD 215-955-6705 maria.werner-wasik@mail.tju.edu | |
| Contact: Rita Axelrod, MD 215-955-8874 rita.axelrod@jefferson.edu | |
| Principal Investigator: Maria Werner-Wasik, MD | |
| Principal Investigator: | Maria Werner-Wasik, MD | Thomas Jefferson University |
More Information
| Study ID Numbers: | 03C.225 |
| Study First Received: | May 19, 2006 |
| Last Updated: | April 23, 2007 |
| ClinicalTrials.gov Identifier: | NCT00328562 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Advanced NSCLC Histologically confirmed unresectable or medically inoperable NSCLC Patients with Stage IV NSCLC needing radiation therapy |
|
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer |
Protein Kinase Inhibitors Gefitinib Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
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 |
