Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.|
- 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.
|Study Start Date:||July 2002|
|Study Completion Date:||March 2013|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|