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Completed

NCT Number: NCT00200395

OSI-774 (Erlotinib, Tarceva) in Elderly Patients

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.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Medical Center, New York, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tarceva

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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