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Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)

Phase 2
65 Years
Not Enrolling
Non-Small Cell Lung Cancer

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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:


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


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Beth Israel Medical CenterNew York, New York  10003
Albert Einstein Cancer CenterBronx, New York  10461
New York UniversityNew York, New York  10016
Montefiore Medical Center-Bronx, New York  10467