A Phase II Evaluation of Avastin in Combination With Docetaxel and Carboplatin as Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer
Avastin® is a humanized monoclonal antibody that binds to vascular endothelial growth factor
(VEGF). VEGF plays an important role in the growth of both normal and abnormal blood
vessels. Avastin® is designed to prevent or slow down the growth of cancer cells by
blocking the effects of VEGF.
Docetaxel and carboplatin are standard chemotherapy drugs that have been approved by the FDA
for the treatment of NSCLC. Docetaxel and carboplatin are designed to work by stopping the
division of cancer cells.
If you are found to be eligible, you will begin receiving Avastin®, docetaxel, and
carboplatin. Avastin®, carboplatin, and docetaxel will be given by vein once every 3 weeks.
The first dose of Avastin® will be given over 90 minutes. The second dose of Avastin® will
be given over 60 minutes. All other doses of Avastin® will be given over 30 minutes.
Carboplatin and docetaxel will always be given over 30 minutes. They will be given on the
same day every 3 weeks (1 cycle). You may receive up to 6 cycles of treatment. You will
receive standard premedication with dexamethasone to help decrease the risk of side effects.
Dexamethasone will be taken before you receive your docetaxel infusion.
During the study, you will have blood tests (about 2 teaspoons) every 3 weeks to look at
your blood counts. These samples will be used only for routine lab tests. You will be seen
by a physician every 3 weeks and given a physical exam. Your blood pressure will be
monitored, and you will be asked about any side effects you are experiencing. A performance
status evaluation will also be done. In addition, you will have a urine test every 2 cycles
After 2 cycles of treatment (6 weeks), you will have a chest x-ray and computerized
tomography (CT) or magnetic resonance imaging (MRI) scan to evaluate the status of the
disease. These will be repeated every 2 cycles. Your continued participation in this study
depends on how your cancer responds to the study drugs. Your doctor may decide to take you
off this study if you experience significant side effects or your medical condition worsens.
You may continue receiving bevacizumab for as long as your cancer responds to study
You will be followed-up on by phone or at routine clinic visits for at least 12 months to
monitor your condition and disease status.
This is an investigational study. Avastin® has been approved by the FDA for the treatment
of colorectal cancer. Docetaxel and carboplatin are FDA approved and commercially
available. The use of these drugs together in this study is experimental. A total of 50
patients will take part in this study. All participants will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-Free Survival (PFS)
Baseline (enrollment) to 12 months or disease progression/death
William N. William Jr., MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|Lyndon Baines Johnson General Hospital||Houston, Texas 77030|