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The goal of this clinical research study is to find the highest tolerable combination dose of bendamustine and bevacizumab that can be given to patients with advanced cancer. The safety of the drug combination will also be studied.
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.
Signing this consent form does not mean that you will be able to take part in this study. You will have "screening tests" to help the doctor decide if you are eligible to take part in this study. The following tests and procedures will be performed:
- Your medical history will be recorded, and you will be asked about any drugs that you may be taking.
- You will have a physical exam, including measurement of your height, weight, and vital signs (blood pressure, breathing rate, heart rate, and temperature).
- You will be asked how well you are able to perform the normal activities of daily living (performance status).
- Blood (about 1 tablespoon) and urine will be collected for routine tests. This urine will also be used for a pregnancy test for women who are able to become pregnant. To take part in this study, the pregnancy test must be negative.
- Blood (about 1 tablespoon) will be drawn to test for tumor markers. Tumor markers are chemical "markers" in the blood that may be related to the status of the disease.
- You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
- If you have not had a chest x-ray, computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, positron emission tomography (PET) scan, and/or a PET/CT scan within the last month, these scans 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. The study doctor will explain these other types of scans to you in more detail, and you may be asked to sign a separate consent form that describes the scans and their risks in more detail.
The study doctor will discuss the results of the screening tests with you. If the screening tests show that you are not eligible to take part in the study, you will not be enrolled. Other options will be discussed with you.
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 study cycle.
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, breast 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
Published on BioPortfolio: 2014-08-27T03:12:37-0400
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