Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
- Registration Number
- NCT00416650
- Lead Sponsor
- Vanderbilt-Ingram Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Therapeutic Intervention erlotinib hydrochloride Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.
- Primary Outcome Measures
Name Time Method Major objective response rate (complete response and partial response) 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
- Secondary Outcome Measures
Name Time Method Worst grade toxicity 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 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 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.
Trial Locations
- Locations (4)
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