Phase I Trial of Intraperitoneal Oxaliplatin and Paclitaxel Plus Intravenous Paclitaxel and Bevacizumab in the Treatment of Advanced Peritoneal Carcinomatosis
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.
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.
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."
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, Positron emission tomography (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 will be taken off study if the disease gets worse or intolerable side effects occur.
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 MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD)
Continual assessment during each 21 day cycle
Apostolia Tsimberidou, MD, PhD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|