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Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent 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: NCT00085280
Recruitment Status : Completed
First Posted : June 11, 2004
Last Update Posted : March 31, 2014
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief Summary:
This clinical trial is studying how well erlotinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Condition or disease Intervention/treatment Phase
Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer Drug: erlotinib hydrochloride Other: laboratory biomarker analysis Not Applicable

Detailed Description:


I. Prospectively identify downstream markers of EGFR linked signaling pathways that are predictive of response to OSI-774 (Erlotinib) in this population.


I. Estimate antitumor objective response rate per RECIST. II. Estimate disease control rate (CR+PR+SD). III. Estimate time to progression and overall survival. IV. Estimate if a grade 2 rash is a predictor of response to OSI-774 (Erlotinib) and of patient survival.

V. Assess safety profile of OSI-774 (Erlotinib) in this population. VI. To determine whether smoking status is linked to outcome for advanced NSCLC patients treated with OSI-774 (Erlotinib).

OUTLINE: This is a pilot, multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment.

After completion of study treatment, patients are followed every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 129 patients will be accrued for this study within 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Determine if Downstream Markers of EGFR Linked Signaling Pathways Predict Response to OSI-774 (Erlotinib) in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Study Start Date : September 2004
Actual Primary Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Treatment (erlotinib hydrochloride)

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients complete the Smoking Status Survey, a questionnaire regarding smoking habits, at baseline, and then every 3 months during study treatment.

Drug: erlotinib hydrochloride
Given orally
Other Names:
  • CP-358,774
  • erlotinib
  • OSI-774

Other: laboratory biomarker analysis
Correlative studies

Primary Outcome Measures :
  1. Response rates and distribution of the mitogen-activated protein kinase (MAPK)/extracellular-signal-regulated kinase (Erk)-phosphorylated expression groups based on the Response Evaluation Criteria in Solid Tumors (RECIST) [ Time Frame: Up to 5 years ]
    A Fisher's exact test with a two-sided 5% type I error rate will be calculated.

Secondary Outcome Measures :
  1. Objective response rate based on the RECIST [ Time Frame: Up to 5 years ]
  2. Disease control rate (complete response [CR]+partial response [PR]+stable disease [SD]) [ Time Frame: Up to 8 weeks ]
  3. Time to progression [ Time Frame: Date of entry on the study to the appearance of new metastatic lesions or objective tumor progression, up to 5 years ]
  4. Overall survival [ Time Frame: Up to 5 years ]
  5. Toxicities associated with erlotinib hydrochloride, based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v3.0 [ Time Frame: Up to 5 years ]
  6. Relationship between clinical response and each of the markers using the semiquantitative histo-score method [ Time Frame: Baseline ]
    Cox regression models will be used.

  7. Effects of smoking status in terms of disease and survival [ Time Frame: Up to 5 years ]
    Descriptive and summary statistics will be conducted on the smoking questionnaire data.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients must have pathologically confirmed NSCLC
  • Patients must have diagnostic specimen available on paraffin-embedded block
  • Patients must have advanced NSCLC (stage IIIB with a malignant pleural effusion or IV disease, or recurrent disease)
  • Patients must not have received prior chemotherapy or targeted therapy for metastatic disease, including no prior EGFR inhibitor; patient may have received adjuvant chemotherapy for early stage disease (IB-IIIA), or chemo/XRT for stage IIIA or IIIB disease, provided s/he meets all of the following:

    • It has been at least 6 months since completion of patient's adjuvant chemotherapy for early stage disease (IB-IIIA) or chemo/XRT for stage IIIA or IIIB disease
    • Patient now has advanced disease
  • Patients must have measurable disease per RECIST criteria; all sites of disease must be assessed within 4 weeks prior to registration
  • Creatinine < 1.5 mg/dL or a creatinine clearance of > 50 mL/min
  • SGOT(AST) and SGPT(ALT) < 2 x the institution's upper limit of normal
  • Bilirubin < 1.5 mg/dL
  • ANC > 1500/mm^3
  • PLT > 100,000/mm^3
  • Patients must have ECOG performance status 0, 1, or 2
  • Patients with stable, treated brain metastases are eligible (defined as: patients with brain metastases must have been treated and are asymptomatic and are no longer taking corticosteroids)
  • Patients with gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease, are ineligible
  • Pregnant and breast feeding women are excluded from the study because the agent used in this study may be teratogenic to a fetus and there is no information on the excretion of the agents or their metabolites into breast milk
  • Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception (hormonal or barrier methods, abstinence) for the duration of the study
  • HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774 (Erlotinib)
  • Patients must not have had immuno, hormonal or radiation therapy within 2 weeks prior to entering the study; those who have not recovered from adverse events due to agents administered more than 2 weeks earlier are ineligible; previously irradiated areas can be considered "measurable disease" if there has been documented progression
  • Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements
  • Patients must not have serious non-healing wound, or bone fracture, or major surgical procedure within 21 days prior to study entry
  • Patients taking Warfarin are eligible
  • If the patient is taking Cyp3A4 inducers or inhibitors, they must be discontinued one week prior to starting OSI-774 (Erlotinib)
  • Patients must not be enrolled in any other concurrent clinical trials

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): NCT00085280

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United States, Massachusetts
Eastern Cooperative Oncology Group
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
National Cancer Institute (NCI)
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Principal Investigator: Julie Brahmer Eastern Cooperative Oncology Group

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute (NCI) Identifier: NCT00085280     History of Changes
Other Study ID Numbers: NCI-2012-03147
NCI-2012-03147 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
U10CA021115 ( U.S. NIH Grant/Contract )
E3503 ( Other Identifier: Eastern Cooperative Oncology Group )
E3503 ( Other Identifier: CTEP )
First Posted: June 11, 2004    Key Record Dates
Last Update Posted: March 31, 2014
Last Verified: January 2013

Additional relevant MeSH terms:
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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