Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)
65 Years
N/A
Both
Non-Small Cell Lung Cancer
Trial Information
Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)
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).
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Principal Investigator
Lakshmi Rajdev, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Montefiore Medical Center
Authority:
United States: Food and Drug Administration
Study ID:
Tarceva
NCT ID:
NCT00200395
Start Date:
June 2003
Completion Date:
Related Keywords:
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
Name | Location |
|---|---|
| Beth Israel Medical Center | New York, New York 10003 |
| Albert Einstein Cancer Center | Bronx, New York 10461 |
| New York University | New York, New York 10016 |
| Montefiore Medical Center- | Bronx, New York 10467 |
