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Erlotinib in Patients With Resected, Early Stage NSCLC With Confirmed Mutations in the EGFR
This study is currently recruiting participants.
Verified by Massachusetts General Hospital, December 2007
Sponsors and Collaborators: Massachusetts General Hospital
Dana-Farber Cancer Institute
Genentech
Information provided by: Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00567359
  Purpose

In this research study erlotinib will be given to eligible participants whose lung cancer has been removed by surgery. Eligible patients have adenocarcinoma, a type of non-small lung cancer, and must have 1 or more of the following characteristics: be female, be of Asian or Pacific Rim descent and/or be a never smoker. The potential participant's tumor will be examined for Epidermal growth factor (EGFR) mutations. EGFR is a protein that is overexpressed in most non-small cell lung cancers. Some EGFR has been found to have specific mutations and the participant must have one of these mutations in his tumor.

Erlotinib blocks this protein and may control tumor growth and increase survival. Previous research has shown that erlotinib is most effective for people who have these specific mutations in the EGFR.


Condition Intervention Phase
Non-Small Cell Lung Cancer
Drug: Erlotinib
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Erlotinib Erlotinib hydrochloride Epidermal Growth Factor
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of Adjuvant Erlotinib in Patients With Resected, Early Stage Non-Small Cell Lung Cancer (NSCLC) With Confirmed Mutations in the Epidermal Growth Factor Receptor (EGFR)

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To determine the 2-year disease-free survival of patients with resected, early stage NSCLC who have activating mutations in the EGFR gene, after treatment with adjuvant erlotinib. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety and tolerability of 2 years of adjuvant erlotinib. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To determine overall survival of this patient sample. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: December 2007
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erlotinib
    Oral drug taken daily around the same time.
Detailed Description:
  • Erlotinib is a pill taken daily and participants may continue to receive erlotinib for up to two years, as long as the cancer does not return and they do not experience any unacceptable side effects.
  • While participants are receiving erlotinib, they will be asked to return to the clinic for study visits to monitor the status of their disease and their general health. For the first 5 months of erlotinib, they will return to the clinic monthly. After that they will return to the clinic every three months.
  Eligibility

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

Inclusion Criteria:

  • Pathologically confirmed diagnosis of NSCLC of adenocarcinoma histology
  • Stage IA-B, IIA-B, or IIIA by the American Joint Committee on Cancer 6th edition staging criteria
  • Patients must have undergone surgical resection with curative intent within 6 months of enrollment
  • Sufficient tumor tissue available for EGFR mutation analysis
  • At least ONE of the following patient characteristics: previously detected deletion 19 or L858R EGFR mutation, female sex, history of never smoking, or Asian/Pacific Rim ethnicity (to be enrolled in the screening portion of trial).
  • 18 years of age or older
  • Tumor samples must have either exon 19 deletion mutations or the exon 21 L858R point mutation
  • ECOG Performance status of 0,1, or 2
  • Adequate organ function as outlined in protocol

Exclusion Criteria:

  • Radiographic evidence of recurrent NSCLC prior to erlotinib treatment
  • Confirmed T790M resistance mutation in the primary tumor sample
  • Prior exposure to EGFR tyrosine kinase inhibitors
  • Known hypersensitivity to erlotinib, gefitinib, or any closely related drug
  • Pregnant or breastfeeding women
  • Any evidence of clinically active interstitial lung disease
  • Current use of enzyme-inducing anti-epileptic drugs, including carbamazepine, oxcarbazepine, phenytoin, fosphenytoin, phenobarbital, and primidone
  • Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
  • Use of any non-FDA approved or investigational agent within 2 weeks of enrolling onto the trial, or failure to recover from the side effects of any of these agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567359

Contacts
Contact: Lecia Sequist, MD, MPH 617-726-7812 lvsequist@partners.org
Contact: Patricia Ostler, RN 617-724-7829 postler@partners.org

Locations
United States, Massachusetts
Massachusetts General Hosptial Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Lecia V. Sequist, MD, MPH            
Dana-Farber Cancer Institute Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Pasi Janne, MD            
Sponsors and Collaborators
Massachusetts General Hospital
Dana-Farber Cancer Institute
Genentech
Investigators
Principal Investigator: Lecia V. Sequist, MD, MPH Massachusetts General Hospital
  More Information

Responsible Party: Massachusetts General Hospital ( Lecia Sequist, MD, MPH )
Study ID Numbers: 07-259
Study First Received: November 30, 2007
Last Updated: December 28, 2007
ClinicalTrials.gov Identifier: NCT00567359  
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
NSCLC
erlotinib
epidermal growth factor receptor
EGFR

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
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