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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00200395
Recruitment Status : Suspended
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Genentech, Inc.
Information provided by:
Montefiore Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Drug: Erlotinib (drug) Phase 2

Detailed Description:
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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : June 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  1. Response rate

Secondary Outcome Measures :
  1. Evaluation of the toxicity of oral OSI-774 administration
  2. Estimation of disease-related symptom improvement rates in elderly patients with inoperable or advanced stage NSCLC
  3. Survival
  4. Duration of stable disease
  5. Progression-free survival

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00200395

United States, New York
Albert Einstein Cancer Center
Bronx, New York, United States, 10461
Montefiore Medical Center-
Bronx, New York, United States, 10467
Beth Israel Medical Center
New York, New York, United States, 10003
New York University
New York, New York, United States, 10016
Sponsors and Collaborators
Montefiore Medical Center
Genentech, Inc.
Study Chair: Lakshmi Rajdev, M.D. Montefiore Medical Center Identifier: NCT00200395     History of Changes
Other Study ID Numbers: Tarceva
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: September 20, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action