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Erlotinib in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085280
  Purpose

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This clinical trial is studying how well erlotinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.


Condition Intervention
Lung Cancer
Drug: erlotinib hydrochloride

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Pilot Study To Determine If Downstream Markers of EGFR Linked Signalling Pathways Predict Response To OSI-774 (Erlotinib) In First-Line Treatment Of Patients With Advanced Non-Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 129
Study Start Date: September 2004
Estimated Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine downstream markers of epidermal growth factor receptor-linked signaling pathways that are predictive of response to erlotinib in patients with stage IIIB or IV or recurrent non-small cell lung cancer.

Secondary

  • Determine antitumor objective response rate in patients treated with this drug.
  • Determine disease control rate (complete response, partial response, or stable disease) in patients treated with this drug.
  • Determine time to progression and overall survival of patients treated with this drug.
  • Determine whether a grade 2 rash is a predictor of response to this drug and of survival of these patients.
  • Determine the safety profile of this drug in these patients.
  • Correlate smoking status, as measured by the Smoking Status Survey, with disease outcome and overall survival in patients treated with this drug.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed non-small cell lung cancer (NSCLC)*

    • Stage IIIB with malignant pleural effusion or IV or recurrent disease NOTE: *Must have diagnostic specimen available on paraffin-embedded block
  • Measurable disease

    • Previously irradiated areas are considered measurable if there is documented disease progression
  • Stable, treated brain metastases allowed provided patients are asymptomatic and not taking corticosteroids

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count > 1,500/mm^3
  • Platelet count > 100,000/mm^3

Hepatic

  • AST and ALT < 2 times upper limit of normal
  • Bilirubin < 1.5 mg/dL

Renal

  • Creatinine < 1.5 mg/dL OR
  • Creatinine clearance > 50 mL/min

Cardiovascular

  • No unstable angina pectoris
  • No symptomatic congestive heart failure
  • No symptomatic cardiac arrhythmia

Gastrointestinal

  • No requirement for IV alimentation
  • No active peptic ulcer disease
  • No gastrointestinal tract disease resulting in an inability to take oral medication

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No bone fracture
  • No serious non-healing wound
  • No active or ongoing infection
  • No psychiatric illness that would preclude study compliance
  • No comorbidity that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 2 weeks since prior immunotherapy and recovered
  • No concurrent routine myeloid growth factors

Chemotherapy

  • No prior chemotherapy for metastatic disease

    • Prior adjuvant chemotherapy for stage IB-IIIA disease OR chemoradiotherapy for stage IIIA or IIIB disease allowed provided both of the following criteria are met:

      • Prior treatment completed ≥ 6 months ago
      • Patient now presents with advanced disease

Endocrine therapy

  • See Disease Characteristics
  • More than 2 weeks since prior hormonal therapy and recovered

Radiotherapy

  • See Disease Characteristics
  • See Chemotherapy
  • More than 2 weeks since prior radiotherapy and recovered

Surgery

  • More than 21 days since prior major surgical procedure
  • No prior surgical procedure affecting absorption

Other

  • No prior epidermal growth factor receptor inhibitors
  • No prior targeted therapy for metastatic disease
  • At least 1 week since prior CYP3A4 inducers or inhibitors
  • Concurrent warfarin allowed
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent grapefruit juice
  • No concurrent enrollment in any other clinical trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085280

  Show 56 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Julie Brahmer, MD Sidney Kimmel Comprehensive Cancer Center
Investigator: Anne M. Traynor, MD University of Wisconsin, Madison
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
Featured trial article  This link exits the ClinicalTrials.gov site

Publications of Results:
Kolesar J, Brahmer J, Lee J, et al.: Final results of ECOG 3503: a pilot study to determine if downstream markers of EGFR linked signaling pathways predict response to erlotinib (OSI-774) in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 25 (Suppl 18): A-7588, 406s, 2007.
Solomon BJ, Roder H, Robert R, et al.: Validation of proteomic classifier for clinical benefit from erlotinib as first line treatment for advanced non-small cell lung cancer (ECOG 3503). [Abstract] J Clin Oncol 25 (Suppl 18): A-7508, 387s, 2007.
Kolesar J, Brahmer J, Li S, et al.: ECOG 3503: a pilot study to determine if downstream markers of EGFR linked signaling pathways predict response to erlotinib (OSI-774) in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC). [Abstract] J Clin Oncol 24 (Suppl 18): A-7162, 404s, 2006.

Other Publications:
Study ID Numbers: CDR0000368459, ECOG-E3503
Study First Received: June 10, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00085280  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Study placed in the following topic categories:
Erlotinib
Thoracic Neoplasms
Non-small cell lung cancer
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Recurrence
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009