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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00416650
Enrollment
16
Registered
2006-12-28
Start date
2002-07-31
Completion date
2013-03-31
Last updated
2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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

DRUGerlotinib hydrochloride

All patients will receive 150 mg orally daily

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Vanderbilt-Ingram Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Major objective response rate (complete response and partial response)At 4 weeks and then every 8 weeksPer 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

MeasureTime frameDescription
Worst grade toxicityweekly for 4 weeks, then every 8 weeks to discontinuation of drugNumber 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 patientsbaseline, every week for 5 weeks, and then every 4 weeksThe 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.
Survivalfrom study entry to date of death or last date known aliveDuration 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026