Lung Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00416650

Recruitment Status:

Completed

Sponsor:

Vanderbilt-Ingram Cancer Center

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There are 4 Locations for this study

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Northwestern Memorial Hospital
Chicago Illinois, 60611, United States
Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States
Vanderbilt-Ingram Cancer Center
Nashville Tennessee, 37232, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 2

Estimated Enrollment:

16

Study ID:

NCT00416650

Recruitment Status:

Completed

Sponsor:


Vanderbilt-Ingram Cancer Center

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