Cetuximab and Vinorelbine in Elderly Subjects With Lung Cancer

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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 vinorelbine in people 70 years of age or older with advanced non-small cell lung cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Bristol-Myers Squibb; Massachusetts General Hospital
• Treatments: Cetuximab; Vinblastine; Vinorelbine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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