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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Genentech
Information provided by (Responsible Party):
Pasi A. Janne, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00137800
First received: August 29, 2005
Last updated: April 5, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention Phase
Non-Small-Cell Lung Carcinoma
 Drug: OSI-774 (Tarceva)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

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

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 OSI-774 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • To determine the survival rate of patients treated with OSI-774 [ Time Frame: TBD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the safety of OSI-774 in people 70 years of age or older [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • To see how OSI-774 affects overall quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: February 2003
Estimated Study Completion Date: December 2013
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: OSI-774 (Tarceva)
    Once daily without interruption as long as there is no disease progression or serious side effects experienced.
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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00137800

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
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: NCT00137800     History of Changes
Other Study ID Numbers: 02-308
Study First Received: August 29, 2005
Last Updated: April 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Non-Small Cell Lung Cancer
Elderly Cancer Patients
Tarceva
 Erlotinib
OSI-774
Stage IIIB or IV Non-Small Cell Lung Cancer

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

ClinicalTrials.gov processed this record on May 22, 2013