Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Genentech
Information provided by (Responsible Party):
Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00137839
First received: August 29, 2005
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.


Condition Intervention Phase
Adenocarcinoma
Non-small Cell Lung Cancer
Drug: Erlotinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Erlotinib (OSI-774); Tarceva in Women With Previously Untreated Advance Adenocarcinoma of the Lung

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine how well non-small cell lung cancer cells in the body respond to Tarceva [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of Tarceva and what effects it has on women with adenocarcinoma of the lung [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: October 2004
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Erlotinib
    Given orally once a day until disease progression or serious side effects occur.
    Other Names:
    • Tarceva
    • OSI-774
Detailed Description:

Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.

Every 28 days (one cycle) while the patient is taking Tarceva, they will be examined in the outpatient clinic (blood test and physical examination) and the doctor will determine if they should continue taking Tarceva.

After every two cycles of treatment (every 8 weeks) standard radiological testing (CT scans, MRIs, and/or x-rays) of the cancer site(s) will be done to assess the response to the Tarceva treatment.

While the patient is on this study and at the end of the study, the patient will undergo blood and urine tests, medical history evaluation, physical exams including measures of vital signs (blood pressure, heart rate, temperature, and respiration), bone scans, tumor biopsy sample, and various radiological tests to monitor the cancer and the patients health.

The length of time on the study depends upon how the cancer responds to Tarceva and whether or not the patient experiences unacceptable side effects.

  Eligibility

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

Inclusion Criteria:

  • Female
  • Diagnosis of adenocarcinoma of the lung
  • Patient has had at least one core biopsy of her tumor
  • Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor
  • Stage IV or IIIB non-small cell lung cancer
  • Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago.
  • Three or more weeks since last radiation therapy
  • Three or more weeks since last major surgery
  • Must at least be able to walk and capable of taking care of herself although unable to carry out work activities
  • Life expectancy of 8 weeks or more
  • Blood tests that show kidneys, liver and bone marrow to be working adequately
  • Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study

Exclusion Criteria:

  • Prior exposure to Tarceva (OSI-774, erlotinib)
  • Uncontrolled central nervous system problems
  • Prior chemotherapy regimen
  • Difficulty swallowing
  • A disease or disorder that interferes with ability to digest and absorb food
  • Incomplete healing of previous oncologic or other major surgery
  • Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure
  • Pregnant or breast feeding
  • A medical condition that could make it unsafe for patient to participate in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137839

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Genentech
Investigators
Principal Investigator: Pasi A Janne, MD, PhD Dana-Farber Cancer Institute
  More Information

Publications:
Responsible Party: Pasi A. Janne, MD, PhD, Associate Professor, Medicine, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00137839     History of Changes
Other Study ID Numbers: 04-253
Study First Received: August 29, 2005
Last Updated: August 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Tarceva
Erlotinib
OSI-774
Adenocarcinoma
Advanced Lung Cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma, Bronchogenic
Respiratory Tract Diseases
Carcinoma
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014