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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00416650
Recruitment Status : Completed
First Posted : December 28, 2006
Last Update Posted : April 4, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
William Pao, MD, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: erlotinib hydrochloride Phase 2

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Phase II Trial of OSI-774 (Erlotinib, Tarceva) in Patients With Advanced Bronchioalveolar Cell Lung Cancer.
Study Start Date : July 2002
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Therapeutic Intervention
Patients will receive erlotinib (OSI-774) 150 mg daily by mouth. If specified toxicities occurs, the dose may be reduced.
Drug: erlotinib hydrochloride
All patients will receive 150 mg orally daily
Other Name: Tarceva, OSI-774

Primary Outcome Measures :
  1. Major objective response rate (complete response and partial response) [ Time Frame: 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 Outcome Measures :
  1. Worst grade toxicity [ Time Frame: 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

  2. Quality of life as measured by the Lung Cancer Symptom Scale for patients [ Time Frame: 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.

  3. Survival [ Time Frame: 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00416650

United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: William Pao, MD Vanderbilt-Ingram Cancer Center

Responsible Party: 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, Vanderbilt-Ingram Cancer Center Identifier: NCT00416650     History of Changes
Other Study ID Numbers: VCC THO 0214
P50CA090949 ( U.S. NIH Grant/Contract )
P30CA068485 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2006    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: March 2013

Keywords provided by William Pao, MD, Vanderbilt-Ingram Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
bronchoalveolar cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action