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| Sponsors and Collaborators: |
Montefiore Medical Center Genentech |
|---|---|
| Information provided by: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00200395 |
Purpose
The purpose of this research study is to determine if OSI-774 (Tarceva) is effective in the treatment of non-small cell lung cancer and to further study its side effects. We would also like to estimate disease-related symptom improvement rates using a questionnaire.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-Small Cell Lung Cancer |
Drug: Erlotinib (drug) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC) |
| Estimated Enrollment: | 27 |
| Study Start Date: | June 2003 |
In recent years, it has been shown that the degree of improvement achievable with chemotherapy has plateaued with the use of chemotherapy doublets. The presence of co-morbid conditions and poor performance status may preclude the use of chemotherapy in many elderly patients, which even in the medically fit, has modest benefits. The advent of targeted cancer therapy with the discovery of tyrosine kinases as mediators of tumor growth, with its limited toxicity profile, offers a promising approach to the treatment of NSCLC, in particular to the elderly subset of patients. The encouraging results from the other trials provide a strong rationale to evaluate an oral EGFR-tyrosine kinase inhibitor OSI-774 in patients with advanced and inoperable NSCLC over the age of 70. In vitro and clinical data suggest a dose- dependent response with Tarceva (Genentech, data on file).
Eligibility| Ages Eligible for Study: | 65 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Montefiore Medical Center- | |
| Bronx, New York, United States, 10467 | |
| Albert Einstein Cancer Center | |
| Bronx, New York, United States, 10461 | |
| New York University | |
| New York, New York, United States, 10016 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| Study Chair: | Lakshmi Rajdev, M.D. | Montefiore Medical Center |
More Information
| Study ID Numbers: | Tarceva |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| ClinicalTrials.gov Identifier: | NCT00200395 |
| Health Authority: | United States: Food and Drug Administration |
|
Erlotinib Thoracic Neoplasms Non-small cell lung cancer Respiratory Tract Diseases Lung Neoplasms |
Lung Diseases Carcinoma, Non-Small-Cell Lung Neoplasms, Glandular and Epithelial Carcinoma |
|
Respiratory Tract Neoplasms Neoplasms Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |
