Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer
Completed · Phase 2
Conditions studied: Non-small Cell Lung Cancer
In brief
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 vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.
Key facts
- Study ID
- NCT00165334
- Run by
- Dana-Farber Cancer Institute
- People needed
- 53
- Starts
- 2005-06-01
- Expected to finish
- 2007-11-01
- Last updated by the study team
- 2009-07-22
Who can join
Age: 70 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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