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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Genentech
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00200395
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  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)

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Response rate

Secondary Outcome Measures:
  • 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
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).

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200395

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
Sponsors and Collaborators
Montefiore Medical Center
Genentech
Investigators
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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014