Phase I Trial of Preoperative Radiotherapy With Concurrent Bevacizumab, Erlotinib and Capecitabine for Locally Advanced Pancreatic Cancer
The Study Drugs:
Bevacizumab is designed to prevent or slow down the growth of cancer cells by blocking the
growth of blood vessels.
Capecitabine and erlotinib hydrochloride are designed to interfere with the growth of cancer
Study Drug Dose Level:
If you are found to be eligible to take part in the study, you will begin receiving
capecitabine, erlotinib hydrochloride, and bevacizumab. The dose you receive will be based
on how many participants have been enrolled before you, and on the safety data that are
available. The first group of enrolled participants will be given low doses of
capecitabine, erlotinib hydrochloride, and bevacizumab. If no intolerable side effects
occur, the next group will be enrolled at a higher dose level. This process will continue
until researchers find the highest dose of capecitabine, erlotinib hydrochloride, and
bevacizumab that can be given without intolerable side effects occurring. The study doctor
will tell you what dose you will be receiving and how it compares to the doses other
participants have received.
Study Drug Administration:
On Days 1, 14, and 28, you will receive bevacizumab through a needle in your vein. Your
first infusion will last about 90 minutes. If you tolerate the drug well, the next infusion
will last about 60 minutes. If the 60-minute infusion is well tolerated, all other
infusions will last about 30 minutes.
On each day that you receive radiation, you will take capecitabine and erlotinib
hydrochloride by mouth in the morning and evening with food.
You will receive radiation once a day on Monday through Friday, excluding holidays. This
schedule will be continue for 5 1/2 weeks or 28 doses.
Every week while you are on study, you will have the following tests and procedures
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will be asked about any side effects you may be experiencing.
- You will repeat the same health questionnaire that you filled out at screening.
Bevacizumab and Surgery:
If at any time during the study the tumor can be removed surgically, you will have surgery.
A separate consent form would be used. Because bevacizumab may slow the healing of wounds,
study participants may not have surgery within 10 weeks after the last bevacizumab infusion.
Length of Study:
You will remain on study for up to 5 1/2 weeks. You will be taken off-study early if the
disease gets worse or intolerable side effects occur.
Four (4) to 6 weeks after you finish radiation, you will have an end-of-study visit with the
following tests and procedures performed:
- You will have a complete physical exam.
- Blood (about 2 tablespoons) and urine will be collected for routine tests.
- You will have chest x-rays and CT scans of the abdomen.
- You will repeat the health questionnaire.
Additional Experimental Therapy:
If you appear to be benefitting from the experimental therapy, the study doctor may decide
to continue your experimental therapy after the end-of-study visit. This would be daily
erlotinib hydrochloride, with bevacizumab infusions every 2 weeks unless the disease gets
worse or intolerable side effects occur. You would have study visits once a month, with the
same procedures as you did during the weekly study visits (except for the questionnaires).
This is an investigational study. Capecitabine, bevacizumab, and erlotinib hydrochloride
are FDA approved and commercially available. The use of capecitabine and bevacizumab for
pancreatic cancer and in combination with erlotinib hydrochloride is investigational. At
this time, the 3-drug combination is being used in research only.
Up to 30 patients will take part in the study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Highest Tolerated Dose of Capecitabine, Erlotinib hydrochloride, and Bevacizumab + Radiation
5 1/2 Weeks
Sunil Krishnan, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|