Trial Information

Summary: A Phase I Study of VEGF Trap Administered with Gemzar and Tarceva

The purpose of this study is to determine the safety and maximum tolerated dose for AVE0005 (VEGF Trap) when given in combination with Gemzar and Tarceva. It will also look at the pharmacokinetics of this drug combination. Pharmacokinetics (PKs) is a method to determine the levels of each drug in the blood and to determine how the body absorbs, distributes, metabolizes and eliminates the drugs when given in combination. This is done by frequent blood draws on key days during the first 4 weeks of the treatment.

Gemzar is an FDA approved drug for the treatment of pancreatic and breast cancer. Tarceva is an FDA approved drug for the treatment of lung cancer and pancreatic cancer. AVE005 (VEGF Trap) is not FDA approved and is investigational. It is a monoclonal antibody that works by blocking angiogenesis (formation of a new blood supply ) to the tumor. It is believed that through the process of angiogenesis, tumors are able to grow and spread.

Patient Inclusion Criteria:

• Confirmed solid tumor malignancy
• Prior Gemzar allowed

Not all eligibility criteria are listed. Additional criteria must be met in order to be eligible.

Patient Exclusion Criteria:

• Diagnosis of squamos cell cancer of the lung
• Uncontrolled hypertension
• History of cardiovascular disease, gastrointestinal disease, the blood clot or stroke within 6 months
• History of bleeding disorders

If you would like to learn more about participating in this study, please send an e-mail message using the form below.