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HAI Abraxane With Gemcitabine and Bevacizumab

2014-08-27 03:16:21 | BioPortfolio

Summary

The goal of this clinical research study is to find the highest tolerable dose of Abraxane® (nab-paclitaxel) when given directly into the liver, in combination with Gemzar® (gemcitabine) and Avastin® (bevacizumab) when given by vein.

Objectives:

1. To determine the toxicity and tolerability of hepatic arterial infusion (HAI) of Abraxane in combination with gemcitabine and bevacizumab in patients with advanced cancers metastatic to the liver.

2. To assess the antitumor efficacy of this combination regimen.

Description

The Study Drugs:

Nab-paclitaxel is designed to block cancer cells from dividing, which may cause the cancer cells to die.

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.

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.

Screening Tests:

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 and surgical history will be recorded.

- 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 3 teaspoons) will be drawn for routine tests and to test your blood's ability to clot.

- Blood (about 3 teaspoons) 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).

- Urine will be collected for routine tests, including a pregnancy test for women who are able to become pregnant. To take part in this study, the pregnancy test must be negative.

- 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 performed within the last month, these scans will be performed to check the status of the disease. If the study doctor thinks it is better for you, other types of scans that have not been listed here may 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 scan and its 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.

Study Groups:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of the combination of nab-paclitaxel and gemcitabine based on when you join this study. Up to 6 dose levels of nab-paclitaxel and gemcitabine will be tested. All participants will receive the same dose level of bevacizumab, regardless of when you join the study. Between 3-6 participants will be enrolled at each dose level. The first group of participants will receive the lowest dose level of the combination of nab-paclitaxel and gemcitabine in combination with bevacizumab. 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 the combination of nab-paclitaxel and gemcitabine given in combination with bevacizumab is found.

Once the highest tolerable dose is found, up to 12 additional participants receive this dose. This is called the expansion group.

Catheter Placement:

On Day 1 of each 21-day study cycle, a catheter (a sterile, flexible tube) will be placed into a large artery that carries blood to the liver in your groin area, on the right side of the body. The area where the catheter will be placed will first be numbed with local anesthetic. The catheter will be taped in place to prevent it from moving or coming out while you are receiving nab-paclitaxel. You will lie flat on your back while receiving the study drug, and you will be on bedrest until the catheter is removed.

The doctor who performs the catheter placement procedure will explain it to you in more detail, and you will be asked to sign a separate consent form that describes the catheter placement procedure and its risks in more detail.

After the catheter is in place, you will receive heparin, a drug that is used to help prevent blood clots. Heparin will be started as soon as the catheter is placed and will continue for up to 2 hours.

The catheter will be removed right after you receive nab-paclitaxel. While the catheter is being removed, the study staff will apply pressure to your groin area for 15 minutes in order to stop the bleeding. The catheter will be in place for about 24 hours, or until the nab-paclitaxel administration is complete.

Study Drug Administration:

Nab-paclitaxel will be given through the catheter into the artery that carries blood to your liver nonstop for 24 hours starting on Day 1 of each cycle. If the study doctor thinks it is needed, you will be given drugs by vein to lower the risk of nausea before each dose as part of your standard, routine care.

Gemcitabine will be given by vein over 1 hour on Days 2 and 8 of each cycle.

Bevacizumab will be given by vein on Day 2 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.

If you do not tolerate the study drug combination well, the doses that you receive may be lowered. If you experience certain side effects, the study drug doses may be delayed and that study cycle may last longer than 21 days.

Study Visits:

-You will stay in the hospital for up to 7 days (Days 1-7 of each cycle) at the beginning of each cycle, until you recover from any side effects that you may experience. You will be seen by a doctor or "advanced practice" nurse every day while you are in the hospital to check on how you are recovering.

On Day 1 of each cycle:

- You will have a physical exam, including measurement of your weight and vital signs.

- Blood (about 3 teaspoons) will be drawn for routine tests, to test your blood's ability to clot, and tumor marker testing.

- Women who are able to become pregnant will have a urine pregnancy test. To remain on this study, the pregnancy test must be negative.

On Day 2 of each cycle:

You will have a physical exam, including measurement of your weight and vital signs.

At the end of every 2 cycles (Cycles 2, 4, 6, and so on), or at any time 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 better for you, other types of scans that have not been listed here may be performed.

Follow-Up Visit:

Six (6) weeks after the last dose of the study drug combination, or if 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 and to test your blood's ability to clot.

- 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 better for you, other types of scans that have not been listed here may 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.

Additional Information:

While you are on study, you should not take any herbal drugs. You must tell the study doctor about any drugs (prescription drugs or over-the-counter drugs) that you may be taking while you are on study.

If you experience any changes in how you are feeling and/or have any health problems while you are on study, you should tell the study doctor right away.

This is an investigational study. Nab-paclitaxel is FDA approved and commercially available when given by vein for the treatment of breast cancer.

Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer, breast cancer that is metastatic (has spread to other parts of the body), non-small cell lung cancer (NSCL), and ovarian cancer. Bevacizumab is FDA approved and commercially available for the treatment of metastatic colorectal cancer, breast cancer, NSCL, and a type of brain cancer called glioblastoma multiforme.

Giving nab-paclitaxel into an artery that carries blood directly into the liver is investigational. Using the study drug combination for treating advanced cancer that has spread to the liver is investigational.

Up to 48 patients will take part in this study. All will be enrolled at M. D. Anderson.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Advanced Cancers

Intervention

HAI Abraxane, Gemcitabine, Bevacizumab

Location

UT MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:21-0400

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