OSI-774 (Erlotinib, Tarceva) in Elderly Patients
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|ClinicalTrials.gov Identifier: NCT00200395|
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : December 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-Small Cell Lung Cancer||Drug: Tarceva||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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.
- Number of participants with treatment-related adverse events as assessed by CTCAE v2.0 [ Time Frame: 1-3 years ]
- 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.
- 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.
- 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.
- Overall Rate of Survival [ Time Frame: Up to 5 years ]
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
|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|
|Study Chair:||Lakshmi Rajdev, M.D.||Montefiore Medical Center|