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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2013-03-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic Intervention

Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.

Group Type EXPERIMENTAL

erlotinib hydrochloride

Intervention Type DRUG

All patients will receive 150 mg orally daily

Interventions

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erlotinib hydrochloride

All patients will receive 150 mg orally daily

Intervention Type DRUG

Other Intervention Names

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Tarceva, OSI-774

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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William Pao, MD

Professor of Medicine, Cancer Biology, & Pathology/ Microbiology/ Immunology; Director, Division of Hematology and Oncology; Ingram Professor of Cancer Research; Director, Personalized Cancer Medicine; Medical Oncologist

Responsibility Role PRINCIPAL_INVESTIGATOR