Status:
COMPLETED
Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Brigham and Women's Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
70+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is it to determine how well patients with non-small cell lung cancer respond to cetuximab plus vinorelbine. We would also like to determine the safety of cetuximab plus vinor...
Detailed Description
* Each cycle of study treatment is 21 days long. Cetuximab will be administered weekly intravenously on days 1, 8 and 15 of the 21-day cycle. * Vinorelbine will be administered intravenously on days 1...
Eligibility Criteria
Inclusion
- 70 years of age or greater
- Stage IV or IIIB Non-small cell lung cancer
- Must at least be able to walk and capable of taking care of yourself although unable to carry out work activities
- 3 or more weeks since completing prior radiotherapy
- 3 or more weeks since prior major surgery
- Blood tests that show your kidneys, liver and bone marrow to be working adequately
- Life expectancy of 8 weeks or more
Exclusion
- Prior anticancer therapy within the past 3 years, including chemotherapy
- Other currently active cancer
- Uncontrolled Central Nervous System (CNS) problems
- Pre-existing disease or abnormality of the nervous system
- Hepatitis or Known HIV
- Active uncontrolled infection
- Incomplete healing from previous major surgery
- Significant history of uncontrolled cardiac disease such as high blood pressure, recent heart attack (within past 6 months), congestive heart failure, etc.
- Prior therapy which targets the ErbB pathway
- Prior severe infusion reaction to an antibody
- Chemotherapy or other investigational agent not indicated in the study protocol occuring at the same time as this study treatment
- A medical condition that could make it unsafe for you to participate in this study
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2007
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00165334
Start Date
June 1 2005
End Date
November 1 2007
Last Update
July 22 2009
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115