Single-Institution Phase II Trial of Oxaliplatin, 5-Fluorouracil, Leucovorin and Bevacizumab (Folfox-B) for Initially Unresectable Colorectal Liver Metastases: Downstaging Followed By Hepatic Resection
Oxaliplatin and bevacizumab are chemotherapy drugs that are designed to kill cancer cells.
5-FU is a chemotherapy drug that helps to stop the growth of cancer cells. Leucovorin is a
drug that may help increase the effect of 5-FU.
The study drugs will be given to you on an outpatient basis and will involve a minimum of 4
cycles and up to a maximum of 12 cycles of chemotherapy. All chemotherapy will be given
through a catheter placed in a vein in the shoulder in "cycles". Each "cycle" equals 14
days. On the first day (Day 1) of each cycle, bevacizumab will be given for 30 to 90 minutes
and oxaliplatin and leucovorin for 2 hours. On Day 1 as well, part of the total 5-FU dose
will be given for 15 minutes through the catheter. The rest of the 5-FU dose is then given
through a pump over the next 46 hours. After 46 hours, you will have a rest period, without
drug treatment for the rest of the cycle until the start of the next cycle.
Before each chemotherapy cycle, you will have blood drawn (about 2 tablespoons) for tests to
check for any side effects. Depending on the results of the blood tests, these blood tests
may be done more often. You will also have your vital signs (blood pressure, breathing,
temperature, and heart rate) monitored during the treatment. You will be seen every 2 weeks
by one of your doctors during your therapy.
If at any time the disease gets worse or you experience any intolerable side effects, you
will be taken off the study.
After completion of the 4th cycle of chemotherapy, you will have a complete physical exam
and routine blood tests (about 2 tablespoons). You will also have a CT scan of the abdomen
and pelvis and a chest x-ray or CT scan of the chest. These tests are being done to find
out if the tumor can be removed by surgery.
If your tumors cannot be removed at this time, you will continue to receive the same dose of
chemotherapy with the same tests for up to a maximum of 12 cycles. If it is found that the
tumor still cannot be removed after 12 cycles, your participation in this study will be
complete and your doctor will discuss other treatment options with you.
If the tumor can be removed, you will receive 1 additional cycle of oxaliplatin, leucovorin,
and 5-FU (no bevacizumab) at the same doses before you go on to have the surgery. Your
surgery will be scheduled 8-12 weeks after the completion of chemotherapy. The surgeon will
explain the surgery and any risks. During liver tumor surgery, normal tissue around the
edges of the tumor will be collected as part of routine care. You will be asked to sign a
separate consent form for the surgery. Additional routine blood tests (about 2 tablespoons)
and a PET scan will be done before surgery.
If you have tumors removed, around 28 days after the surgery, you will be given 8 additional
cycles of bevacizumab given the same way as before surgery.
Around 4-6 weeks after the final chemotherapy treatment, you will have follow-up CT scans of
the abdomen and pelvis, a chest x-ray or CT scan of the chest, and a routine blood test
(about 2 tablespoons). These tests will be repeated every 3 months for the first 3 years
after surgery, every 6 months for the 4th and 5th year after surgery, and then once a year
for the rest of your life. PET scans will be done once a year to check on the status of the
This is an investigational study. Oxaliplatin, 5-FU, leucovorin, and bevacizumab are FDA
approved and commercially available for the treatment of this disease. However, their use
together in this study is investigational. Up to 42 patients 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
Complete Gross Resection Rate
Complete gross resection rate for patients with initially unresectable hepatic colorectal metastasis who are treated with a combination of oxaliplatin/ 5-fluorouracil/ leucovorin/ bevacizumab (Number of Resectable versus Not Resectable Patients).
Over 4 year study period
Eddie Abdalla, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|