Track topics on Twitter Track topics that are important to you
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
Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine alone...
The study design is a non-randomized, open label, single center Phase II trial. Eligible patients are women who have a confirmed diagnosis of ovary, fallopian tube cancer or primary perit...
The purpose of this study is to evaluate the safety and efficacy of Bendamustine (TREANDA™), in combination with Melphalan in subjects with multiple myeloma who are undergoing an Autolog...
Our study aims at assessment of response, survival and toxicity of frontline treatment with chemotherapy and Bevacizumab in patients having advanced epithelial ovarian cancer.
The substudy is a multicenter, open-label study consisting of a subset of the patients in Cephalon study C18083/3064/NL/MN who are receiving the investigational treatment (BR), for the pur...
Large scale randomized controlled trials have demonstrated that the use of bevacizumab in addition to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) conveys significant surv...
Over the past 5 years, addition of bevacizumab to combination chemotherapy for advanced, recurrent, and persistent cervical cancer has offered prolonged overall and progression-free survival. Since th...
Platinum-based chemotherapy plus bevacizumab is the new standard of care in stage IVB cervical cancer (CC) patients. In this new scenario, radical surgery could be offered in selected cases with an op...
Phase III trials have shown improved survival in ovarian cancer patients when the anti-vascular endothelial growth factor (VEGF) therapy bevacizumab is added to first-line chemotherapy. However, furth...
Bevacizumab combined with platinum-taxane chemotherapy as first-line treatment for advanced ovarian cancer: a prospective observational study of safety and efficacy in Japanese patients (JGOG3022 trial).
This was the first large-scale prospective observational Japanese study evaluating the safety and efficacy of bevacizumab combined with paclitaxel and carboplatin for newly diagnosed advanced ovarian ...
An antineoplastic agent that is a derivative of progesterone and used to treat advanced breast cancer.
A nitrogen mustard compound that functions as an ALKYLATING ANTINEOPLASTIC AGENT and is used in the treatment of CHRONIC LYMPHOCYTIC LEUKEMIA and NON-HODGKIN'S LYMPHOMA.
Advanced technology that is costly, requires highly skilled personnel, and is unique in its particular application. Includes innovative, specialized medical/surgical procedures as well as advanced diagnostic and therapeutic equipment.
A cancer registry mandated under the National Cancer Act of 1971 to operate and maintain a population-based cancer reporting system, reporting periodically estimates of cancer incidence and mortality in the United States. The Surveillance, Epidemiology, and End Results (SEER) Program is a continuing project of the National Cancer Institute of the National Institutes of Health. Among its goals, in addition to assembling and reporting cancer statistics, are the monitoring of annual cancer incident trends and the promoting of studies designed to identify factors amenable to cancer control interventions. (From National Cancer Institute, NIH Publication No. 91-3074, October 1990)
An aromatase inhibitor that produces a state of "medical" adrenalectomy by blocking the production of adrenal steroids. It also blocks the conversion of androgens to estrogens. Aminoglutethimide has been used in the treatment of advanced breast and prostate cancer. It was formerly used for its weak anticonvulsant properties. (From Martindale, The Extra Pharmacopoeia, 30th ed, p454)
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...