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OSI-774 (Erlotinib, Tarceva) in Elderly Patients

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.
 
ClinicalTrials.gov Identifier: NCT00200395
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 30, 2019
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
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. The investigators 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: Tarceva 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
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)
Actual Study Start Date : July 2, 2003
Actual Primary Completion Date : January 12, 2007
Actual Study Completion Date : January 12, 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OSI-774 (Tarceva)
Oral treatment with OSI-774 (Tarceva) will be given as a 150 mg tablets daily for 14 days. On day 15 and if there are no adverse effects the dose will be increased to 200 mg.
Drug: Tarceva
OSI-774 will be supplied as 25 mg (non -film coated) 100 and 150 mg (film coated) tablets in separate bottles, containing 30 tablets respectively.
Other Names:
  • OSI-774
  • Erlotinib




Primary Outcome Measures :
  1. Rate of Response [ Time Frame: 1-3 years ]
    The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date the recurrent or progressive disease is documented.


Secondary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v2.0 [ Time Frame: 1-3 years ]
  2. Changes in Quality of Life (QOL): questionnaire [ Time Frame: through study completion, an average of 3 years ]
    This will involve participant response to a seven-item lung cancer subscale of Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire.

  3. Rate of Progression free survival [ Time Frame: 1-3 years ]
    Progression free survival is defined as the duration of time from start of treatment to time of progression.

  4. Duration of stable disease [ Time Frame: 1-3 years ]
    Stable disease is measured from the start of the treatment until the criteris for progression are met., taking as reference the smallest measurements recorded since the treatment started.

  5. Overall Rate of Survival [ Time Frame: Up to 5 years ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00200395


Locations
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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.
Investigators
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Study Chair: Lakshmi Rajdev, M.D. Montefiore Medical Center
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Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00200395    
Other Study ID Numbers: 03-01-019
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: December 30, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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 Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action