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.
OBJECTIVES: Primary * 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. Secondary * 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
All patients will receive 150 mg orally daily
Northwestern Memorial Hospital
Chicago, Illinois, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Major objective response rate (complete response and partial response)
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
Time frame: At 4 weeks and then every 8 weeks
Worst grade toxicity
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
Time frame: weekly for 4 weeks, then every 8 weeks to discontinuation of drug
Quality of life as measured by the Lung Cancer Symptom Scale for patients
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.
Time frame: baseline, every week for 5 weeks, and then every 4 weeks
Survival
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.
Time frame: from study entry to date of death or last date known alive
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