Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00416650|
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : April 4, 2013
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: erlotinib hydrochloride||Phase 2|
- Determine the major objective response rate (partial response and complete response) in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride.
- Assess the quality of life of patients treated with this regimen.
- Determine the duration of response and time to disease progression in patients treated with this regimen.
- Determine the median survival of patients treated with this regimen.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.|
|Study Start Date :||July 2002|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||March 2013|
Experimental: Therapeutic Intervention
Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.
Drug: erlotinib hydrochloride
All patients will receive 150 mg orally daily
Other Name: Tarceva, OSI-774
- Major objective response rate (complete response and partial response) [ Time Frame: At 4 weeks and then every 8 weeks ]Per Response Evaluation in Solid Tumors (RECIST) criteria v. 1.1: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions
- Worst grade toxicity [ Time Frame: weekly for 4 weeks, then every 8 weeks to discontinuation of drug ]Number of patients with worst-grade toxicity at each of five grades (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, disabling, 5 = death) following NCI Common Toxicity Criteria, v. 2. Drug is discontinued for disease progression, unacceptable toxicity, patient undergoes radiation or other chemotherapy, or withdraws from study
- Quality of life as measured by the Lung Cancer Symptom Scale for patients [ Time Frame: baseline, every week for 5 weeks, and then every 4 weeks ]The Lung Cancer Symptom Scale for patients is a nine-item scale with 0 = lowest rating (least) to 100 = highest rating (worst) for the measurement of symptom burden for loss of appetite, fatigue, cough, dyspnea, hemoptysis, activity, quality of life, lung cancer symptoms, and pain.
- Survival [ Time Frame: from study entry to date of death or last date known alive ]Duration of time from date of study entry to death from any cause or to the last date the patient is known to be alive.
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): NCT00416650
|United States, Illinois|
|Northwestern Memorial Hospital|
|Chicago, Illinois, United States, 60611|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||William Pao, MD||Vanderbilt-Ingram Cancer Center|