Phase II Feasibility Study of FOLFIRINOX-Losartan Followed by Accelerated Short Course Radiation Therapy With Proton Beam for Locally Advanced Pancreatic Cancer
If you are willing to participate in this research study, you will be asked to undergo some
screening tests and procedures to confirm that you are eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if it turns out
that you do not take part in the research study. If you have had some of these tests or
procedures recently, they may or may not have to be repeated. These tests and procedures
will include a medical history, routine physical exam, performance status, assessment of
your tumor, routine blood tests, a blood sample to check your kidney function and a serum or
urine pregnancy test if applicable. If these tests show that you are eligible to participate
in the research study, you will begin the study treatment. If you do not meet the
eligibility criteria, you will not be able to participate in this research study.
There are two phases to this study. Phase I involves FOLFIRINOX and Losartan. The treatment
plant will begin with 8 cycles of FOLFIRINOX. Each cycle is 14 days, or 2 weeks long.
FOLFIRINOX is comprised of four drugs: Oxaliplatin, irinotecan, fluorouracil and leucovorin.
On Day 1 of each 14 day cycle, you will receive oxaliplatin via IV infusion over a period of
2 hours. Irinotecan will be administered via IV infusion on Day 1 of each cycle over a
period of 90 minutes.
You will receive fluorouracil (5FU) on Day 1 of each cycle via IV infusion over a period of
2-4 minutes. You will then be fitted with an ambulatory infusion pump that will be delivered
continuously over 46-48 hours.
In addition to these infusions, FOLFIRINOX will always be administered along with a two
hours IV infusion of leucovorin, a drug composed of reduced folic acid, which helps enhance
the effects of chemotherapy. You will be give leucovorin through a vein in your arm for 2
hours a day on Day 1 of each cycle.
You will also receive an injection of Neulasta after each FOLFIRINOX treatment. Neulasta is
used to reduce the chance of infection from chemotherapy by boosting your white blood cell
count. It will be administered 24-48 hours after your FOLFIRINOX infusion (on Day 3 or 4).
You will take one dose of Losartan by mouth every day during Phase I for all 8 cycles of
FOLFIRINOX. If the dose of Losartan given to you during the first week does not give you any
serious side effects, your dose will be increased once for the remainder of Phase I. We have
provided a drug diary for you with instructions on how to take this tablet and what to do
incase of any missed or vomited doses. We will monitor your response to treatment with a
chest/abdominal CT after four cycles of FOLFIRINOX therapy (8 weeks).
Phase II involves Restaging/Proton Beam Radiation Therapy and Capecitabine. At this time
your study doctor will assess for any progress in your cancer after the FOLFIRINOX +
Losartan treatment again via CT scan. If your cancer has progressed, you will be removed
from the study and continue with standard of care treatment. If it has not progressed, you
will continue to the proton radiation therapy and capecitabine phase of the study.
During this phase you will receive proton beam radiation therapy at the Francis H. Burr
Proton Therapy center for 1 week, Monday through Friday. Each visit is expected to take
During the week of proton radiation therapy and for the week after, you will take
capecitabine by mouth on Monday through Friday, for a total of ten days. You will be given a
drug diary with instructions on how to take capecitabine and what to do in case of a missed
or vomited dose.
You will receive the following tests and procedures at various time points during both
portions of the study. These tests and procedures will include: routine blood tests, blood
sample to check kidney function, CA19-9 and CEA blood tests, Chest CT/Abdominal-Pelvic CT,
assessment for side effects, vital signs, performance status, routine physical exam and
blood pressure monitoring.
After the final dose of study drug you will come into the clinic for follow-up visits for
some assessments every 3 months until your cancer progresses. You will undergo the following
tests: routine physical exam, vital signs, performance status, routine blood tests,
assessment for side effects. In addition you are required to have a chest and
abdominal/pelvic CT every 6 months for the first two years, and yearly for years 3-5. We
would like to keep track of your medical condition for the rest of your life. We would like
to do this by calling you on the telephone once a year to see how you are doing. Keeping in
touch with you and checking on your condition every year helps us look at the long term
effects of the research study.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of combining FOLFIRINOX-Losartan
To determine the feasibility of the combination of FOLIRINIOX-Losartan in patients with locally advanced unresectable pancreas cancer determining the proportion free of radiographic progression at the time of restaging and consideration of proton therapy after induction chemotherapy
Theodore Hong, MD
Massachusetts General Hospital
United States: Food and Drug Administration
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|