Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients

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: NCT00137800
Recruitment Status : Active, not recruiting
First Posted : August 30, 2005
Last Update Posted : August 3, 2016
Massachusetts General Hospital
Brigham and Women's Hospital
Genentech, Inc.
Information provided by (Responsible Party):
Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute

Brief Summary:
The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs, when given to subjects with non-small cell lung cancer, who are 70 years of age or older.

Condition or disease Intervention/treatment Phase
Non-Small-Cell Lung Carcinoma Drug: OSI-774 (Tarceva) Phase 2

Detailed Description:

Patients will receive OSI-774 once daily without interruption. There are no pre-determined number of cycles or planned dose interruptions. For the purposes of evaluation, toxicity and efficacy, a four week (28 day period) will be considered 1 cycle.

Patients will continue to receive OSI-774 until they develop progressive disease, unacceptable side-effects or wish to withdraw from the study.

Patients will have radiographic evaluations after every two cycles of therapy. After cycle 2, patients will also be evaluated by FDG-PET scanning.

Patients will also be asked to fill out a Lung Cancer Symptom Scale (LCSS) on the first day of each cycle.

Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of OSI-774 (Tarceva) in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : February 2003
Primary Completion Date : May 2005
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

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

Intervention Details:
    Drug: OSI-774 (Tarceva)
    Once daily without interruption as long as there is no disease progression or serious side effects experienced.

Primary Outcome Measures :
  1. To determine how well non-small cell lung cancer cells in the body respond to OSI-774 [ Time Frame: 2 years ]
  2. To determine the survival rate of patients treated with OSI-774

Secondary Outcome Measures :
  1. To determine the safety of OSI-774 in people 70 years of age or older [ Time Frame: 2 years ]
  2. To see how OSI-774 affects overall quality of life [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age: 70 years of age or older
  • Stage IV or IIIB non-small cell lung cancer (NSCLC)
  • Measurable tumor(s)
  • Three or more weeks since prior radiation therapy
  • Three or more weeks since prior major surgery
  • Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities.
  • Must be up and about more than 50% of waking hours.
  • Life expectancy of 8 weeks or more
  • Blood tests that show kidneys, liver and bone marrow to be working adequately
  • Completely healed from previous oncologic or other major surgery

Exclusion Criteria:

  • Prior chemotherapy regimen for non-small cell lung cancer
  • Prior exposure to OSI-774 or similar treatments such as trastuzumab, ZD1839, C225, etc.
  • Uncontrolled central nervous system metastases
  • Concurrent active cancer
  • Malignancies within the past 5 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
  • Prior chemotherapy for any malignant disease
  • Difficulty swallowing
  • A disease or disorder that interferes with ability to digest and absorb food
  • A medical condition that could make it unsafe for patient to participate in this study

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): NCT00137800

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Genentech, Inc.
Principal Investigator: Pasi A Janne, MD, PhD Dana-Farber Cancer Institute

Responsible Party: Pasi A. Janne, MD, PhD, Associate Professor, Medicine, Dana-Farber Cancer Institute Identifier: NCT00137800     History of Changes
Other Study ID Numbers: 02-308
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016

Keywords provided by Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute:
Non-Small Cell Lung Cancer
Elderly Cancer Patients
Stage IIIB or IV 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