Phs. II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients W/Advanced Stage or Inoperable Non-Small Cell Lung Cancer (NSCLC)
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC) |
- Response rate
- Evaluation of the toxicity of oral OSI-774 administration
- Estimation of disease-related symptom improvement rates in elderly patients with inoperable or advanced stage NSCLC
- Survival
- Duration of stable disease
- Progression-free survival
| 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:
- Patients must have confirmed non-small cell lung cancer. Age > 65 years Patients must have adequate organ and marrow function
Exclusion Criteria:
- Patients who have had prior chemotherapy will be excluded. Patients may not be receiving any other investigational agents.
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
No publications provided
| ClinicalTrials.gov Identifier: | NCT00200395 History of Changes |
| Other Study ID Numbers: | Tarceva |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 13, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Erlotinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013