Lung Cancer
Conditions
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, bronchoalveolar cell lung cancer, recurrent non-small cell lung cancer
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.
Interventions
All patients will receive 150 mg orally daily
Sponsors
Study design
Eligibility
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States