Tissue Pharmacokinetics of Intraoperative Gemcitabine in Resectable Adenocarcinoma of the Pancreas
The Study Drug:
Gemcitabine is a drug used to treat pancreatic cancer. However, there are no studies that
show that gemcitabine is able to enter pancreatic cancer cells.
Your surgery will be performed in the same way as it would be even if you were not taking
part in this study. You will sign a separate consent form for surgery. The length of the
surgery and the time you are under anesthesia are not changed by taking part in the study.
To try to find out if gemcitabine enters pancreas cancer cells, participants who are having
their pancreatic cancer removed by surgery will receive an infusion of gemcitabine during
the surgery. Some of the pancreatic cancer tissue removed then will be checked to learn if
gemcitabine is found in the cancer cells.
During surgery, you will have routine procedures to learn if the disease has spread to other
areas. If the disease has spread beyond the pancreas, surgical removal is not possible.
If for any reason during the surgery, the surgeon decides that removal of the pancreas is
not possible, you will not receive gemcitabine and your participation in this study will
If there are no signs of spread or other reasons the cancer cannot be removed, the surgeon
will begin the process of removal of the disease.
You will receive an infusion of gemcitabine just before the surgeon begins to remove the
cancer. Gemcitabine will be given through an infusion catheter that is placed in the
operating room after you are asleep. The infusion will take over either 50 or 100 minutes,
depending upon when you joined the study. The first 2 participants will receive gemcitabine
over 50 minutes and the rest of the participants (up to 18) will receive gemcitabine over
100 minutes. The infusion catheter is not required for the study but is a standard of care
procedure for all participants who are having pancreatic cancer surgery. You will sign a
separate consent form for the infusion catheter.
Blood and Tissue Collection:
Up to 10 blood samples (about 1 tablespoon each time) will be drawn during surgery starting
before the gemcitabine infusion begins and at the end of surgery. The blood samples are
used to measure the levels of gemcitabine in your blood at different time points. This is
called pharmacokinetic (PK) testing. The blood will also be used for biomarker testing.
Biomarkers are chemical "markers" in the blood/tissue that may be related to your reaction
to the study drug.
Some of the tumor tissue and normal tissue removed during surgery will be collected to learn
if gemcitabine is able to enter the tissue cells and for biomarker testing.
Length of Study:
Your active participation in this study will be over once you have had surgery and completed
the follow-up. The research team will continue to collect information on you for 30 days
after surgery (or until you are no longer having side effects).
The study team will follow your health status for 30 days after surgery to check if you are
having any side effects from gemcitabine. This follow-up will be done daily while you are
in the hospital recovering from the surgery. Follow-up will also occur at the time of a
routine clinic visit, or by phone call at least once weekly. These calls should last about
5 minutes each.
This is an investigational study. Gemcitabine is FDA approved and commercially available
for the treatment of pancreatic cancer. Its use during surgery is investigational.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intratumoral Gemcitabine Levels in Human Pancreatic Cancer Tissue
Pharmacokinetic (PK) Testing of up to 10 blood samples (about 1 tablespoon each time) drawn during surgery starting before gemcitabine infusion and at end of surgery. Blood samples used to measure levels of gemcitabine in blood at the different time points.
Collection during surgery, patients followed 30 days post surgery
Jason B Fleming, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|