A Phase I Study of Bendamustine and Bevacizumab for Patients With Advanced Cancers
The Study Drugs:
Bendamustine is designed to damage DNA (the genetic material) of cancer cells. Bendamustine
also interferes with the creation of new DNA, which may keep cancer cells from repairing
themselves or forming new cancer cells.
Bevacizumab is designed to block the growth of blood vessels that supply the nutrients
needed for tumor growth, which may prevent or slow down the growth of cancer cells.
Bevacizumab is no longer FDA approved to treat breast cancer.
If you are found to be eligible to take part in this study, you will be assigned to a dose
level of bendamustine based on when you join this study. Up to 4 dose levels of
bendamustine will be tested. Up to 3 participants will be enrolled at each dose level. The
first group of participants will receive the lowest dose level. Each new group will receive
a higher dose than the group before it, if no intolerable side effects were seen. This will
continue until the highest tolerable dose of bendamustine is found.
All participants will receive the same dose level of bevacizumab.
Study Drug Administration:
You will receive bendamustine by vein over 30-60 minutes on Days 1 and 2 of each 28-day
You will receive bevacizumab by vein on Days 1 and 15 of each cycle. The first time you
receive bevacizumab, it will be given over 90 minutes. If you tolerate it well, the rest of
the doses will be given over 30-60 minutes.
On Day 1 of each cycle:
- You will have a physical exam, including measurement of your weight and vital signs.
- Blood (about 1 tablespoon ) will be drawn for routine tests.
- Women who are able to become pregnant will have a urine pregnancy test.
Every 2 cycles (Cycles 2, 4, 6, and so on):
- Blood (about 1 tablespoon) will be drawn to test for tumor markers.
- A chest x-ray, CT scan, MRI scan, PET scan, and/or PET/CT scan will be performed to
check the status of the disease. These scans will also be performed at any time that
the doctor thinks it is needed to check the status of the disease. If the study doctor
thinks it is in your best interest, other types of scans that have not been listed here
may also be performed.
Length of Study:
You may continue taking the study drug combination for as long as the doctor thinks it is in
your best interest. You will no longer be able to take the study drug if the disease gets
worse or intolerable side effects occur.
Six (6) weeks after you stop taking the study drug combination for any reason, the following
tests and procedures will be performed:
- You will have a physical exam.
- Your performance status will be recorded.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- If the study doctor thinks it is needed, a chest x-ray, CT scan, MRI scan, PET scan
and/or PET/CT scan will be performed to check the status of the disease. If the study
doctor thinks it is in your best interest, other types of scans that have not been
listed here may also be performed.
This is an investigational study. Bendamustine is FDA approved and commercially available
for the treatment of chronic lymphoid leukemia and non-Hodgkin's lymphoma. Bevacizumab is
FDA approved and commercially available for the treatment of metastatic colorectal cancer,
non-small-cell lung cancer (NSCLC), and a type of brain cancer called glioblastoma
multiforme. The use of these drugs in combination in advanced cancer is investigational.
Up to 55 participants will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Every 28 days
Apostolia M. Tsimberidou, MD, PhD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|