Status:
COMPLETED
Study of OSI-774 (Tarceva) in Previously Untreated Elderly Lung Cancer Patients
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Brigham and Women's Hospital
Conditions:
Non-Small-Cell Lung Carcinoma
Eligibility:
All Genders
70+ years
Phase:
PHASE2
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 ce...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00137800
Start Date
February 1 2003
End Date
March 1 2007
Last Update
April 3 2020
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215