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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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ClinicalTrials.gov Identifier: NCT00200395
Recruitment Status : Suspended
First Posted : September 20, 2005
Last Update Posted : September 20, 2005
Information provided by:

September 13, 2005
September 20, 2005
September 20, 2005
June 2003
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Response rate
Same as current
No Changes Posted
  • 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
Same as current
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Phs. II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients W/Advanced Stage or Inoperable Non-Small Cell Lung Cancer (NSCLC)
Phase II Study of OSI-774 (Erlotinib, Tarceva) in Elderly Patients With Advanced Stage or Inoperable Non Small Cell Lung Cancer (NSCLC)
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.
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).
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Drug: Erlotinib (drug)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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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.
Sexes Eligible for Study: All
65 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Montefiore Medical Center
Genentech, Inc.
Study Chair: Lakshmi Rajdev, M.D. Montefiore Medical Center
Montefiore Medical Center
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP