Oxaliplatin and Paclitaxel Plus Bevacizumab in Advanced Peritoneal Carcinomatosis
Summary
The goal of this clinical research is to learn acceptable dosages of paclitaxel, oxaliplatin, and Avastin (bevacizumab) that can be given in combination to patients with advanced peritoneal carcinomatosis. The safety of this drug combination will also be studied.
Description
The Study Drugs:
Paclitaxel is designed to block cancer cells from dividing, which may cause them to die.
Oxaliplatin is designed to keep new cancer cells from growing
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels.
Screening Tests:
Before you can receive the study drugs on 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 will be performed:
If you have not had them done in the last month, you will have scans to check the status of the disease. This may include a chest x-ray, a computed tomography (CT) scan, a magnetic resonance imaging (MRI) scan, a positron emission tomography (PET) scan, and/or a PET/CT scan. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form.
- Blood (about 1 tablespoon) and urine will be collected for routine tests. This routine blood draw will include a pregnancy test for women who are able to have children. To be eligible to take part in this study, the pregnancy test must be negative.
- You will have an electrocardiogram (ECG -- a test that measures the electrical activity of the heart).
- Your complete medical history will be recorded.
- You will have a physical exam.
Study Drug Dose Levels:
Up to 12 study drug dose levels will be tested in this study. Participants will be enrolled in groups of 3. The first 3 participants will be enrolled at the lowest dose level. If there are no intolerable side effect seen, the next 3 participants will be enrolled into the next higher dose level. This will continue until acceptable dose levels of the study drugs are found. The dose level that you are assigned to will depend on when you enroll on this study. You will receive the same dose level for the entire study unless you develop side effects, in which case doses of the drugs will be decreased by your doctor.
Drug Administration:
If you agree to participate in this study, you will have a catheter placed in your abdomen before receiving study drug. A catheter is a sterile flexible tube that will be placed while you are under local anesthesia. Your doctor will explain this procedure to you in more detail, and you will be required to sign a separate consent form.
On Day 1, you will receive bevacizumab followed by paclitaxel through a needle in your vein over 24 hours.
On Day 2, after you have completed the paclitaxel infusion, you will be given about 1 quart of fluid containing oxaliplatin into the abdomen through the catheter over 15 minutes.
On Day 8, you will be given about 1 quart of fluid containing paclitaxel into the abdomen through the catheter over 15 minutes.
Every 21 days is called a study "cycle."
Study Visits:
During each cycle, you will see your doctor in his office to make sure that you are still eligible to receive study drugs.
Blood (about 1 tablespoon) will be drawn for routine tests each day during hospitalization and then once a week as an outpatient.
A urine sample will be collected once each cycle for routine tests. You will have scans such as a chest x-ray, CT, MRI, PET, and/or PET/CT scan after every 2 cycles (6 weeks) or earlier if the study doctor thinks it is in your best interest, or the cancer gets worse. These scans are to check the status of the disease. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form.
Length of Study:
You may receive up to 6 cycles of study drugs. You will be taken off study if the disease gets worse or intolerable side effects occur.
End-of-Study Visit:
If you are taken off study, you will be asked to have an end-of-study visit. At this visit, the following tests will be performed:
Blood (about 1 tablespoon) and urine will be collected for routine tests. You will have repeat scans such as a chest x-ray, CT, MRI, PET, and/or PET/CT scan to check the status of the disease. If the study doctor thinks it is more appropriate for you, other types of scans may need to be performed. The study doctor will discuss these scans with you, and you may be asked to sign a separate consent form.
This is an investigational study. Paclitaxel, oxaliplatin, and bevacizumab are FDA-approved drugs, but their use in this study is investigational. Up to 72 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
Peritoneal Cancer
Intervention
Bevacizumab, Oxaliplatin, Paclitaxel
Location
U.T.M.D. Anderson Cancer Center
Houston
Texas
United States
77030
Status
Recruiting
Source
M.D. Anderson Cancer Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00491855
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Peritoneal Dialysis, Continuous Ambulatory
Portable peritoneal dialysis using the continuous (24 hours a day, 7 days a week) presence of peritoneal dialysis solution in the peritoneal cavity except for periods of drainage and instillation of fresh solution.
Peritoneal Neoplasms
Tumors or cancer of the PERITONEUM.
Peritoneal Fibrosis
Disorder characterized by a wide range of structural changes in PERITONEUM, resulting from fibrogenic or inflammatory processes. Peritoneal fibrosis is a common complication in patients receiving PERITONEAL DIALYSIS and contributes to its gradual decrease in efficiency.
Peritoneal Stomata
Natural openings in the subdiaphragmatic lymphatic plexus in the PERITONEUM, delimited by adjacent mesothelial cells. Peritoneal stomata constitute the principal pathways for the drainage of intraperitoneal contents from the PERITONEAL CAVITY to the LYMPHATIC SYSTEM.
Peritoneal Lavage
Washing out of the peritoneal cavity. The procedure is a diagnostic as well as a therapeutic technique following abdominal trauma or inflammation.
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