Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
=================
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.

Official Title
-----------------
Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Drug: erlotinib hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed bronchoalveolar cell (or a variant) non-small cell lung cancer (NSCLC) Stage IIIB (malignant pleural or pericardial effusion) disease Stage IV disease Recurrent and/or medically inoperable disease Measurable or evaluable indicator lesions No uncontrolled CNS metastases (i.e., any known CNS lesion that is radiographically unstable, symptomatic, and/or requiring escalating doses of corticosteroids) PATIENT CHARACTERISTICS: ECOG performance status (PS) 0-1 OR Karnofsky PS 80-100% Life expectancy ≥ 8 weeks WBC ≥ 3,000/mm³ Hemoglobin ≥ 9.0 g/dL Platelet count ≥ 100,000/mm³ Bilirubin ≤ 1.0 mg/dL AST ≤ 2 times upper limit of normal Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 55 mL/min Not pregnant or nursing Fertile patients must use effective contraception No significant medical history or unstable medical condition, including any of the following: Unstable systemic disease Congestive heart failure Recent myocardial infarction Unstable angina Active infection Uncontrolled hypertension No other active malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 3 weeks since prior radiation therapy to a major bone marrow-containing area At least 3 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen for NSCLC No prior systemic cytotoxic chemotherapy for other malignant diseases No prior erlotinib hydrochloride or other agents targeting the HER family (e.g., cetuximab, trastuzumab [Herceptin®], or gefitinib) No concurrent radiotherapy or chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Intervention<br>Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced. | Drug: erlotinib hydrochloride<br>* All patients will receive 150 mg orally daily<br>* Other names: Tarceva, OSI-774;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At 4 weeks and then every 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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. | from study entry to date of death or last date known alive | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, bronchoalveolar cell lung cancer, recurrent non-small cell lung cancer