A Prospective, Randomized, Phase II Study of Preoperative Plus Postoperative Imatinib Mesylate (Gleevec, Formerly STI-571) in Patients With Primary, Recurrent, or Metastatic Resectable, Kit-Expressing, Gastrointestinal Stromal Tumor (GIST)
Imatinib mesylate is a drug that may help to kill gastrointestinal stromal tumor cells.
Around 3 weeks before your scheduled surgery, you will have a PET scan, a CT scan and two to
three tablespoons of blood will be collected. These are imaging tests and are being done to
check on the status of the disease. These tests will be repeated the day before your
scheduled surgery. If your doctor feels it is necessary, you will have a chest x-ray and 2
to 3 tablespoons of blood will be collected for routine tests. Women who are able to have
children must have a negative blood pregnancy test.
Before treatment, you will also have a biopsy procedure of the tumor performed. This biopsy
is being done to study the effect of imatinib mesylate on the tumor cells. The tissue that
is collected during the biopsy procedure will be compared to the tumor that is taken out at
the time of surgery.
You will be randomly assigned (as in the toss of a coin) to one of three groups. One group
will begin taking imatinib mesylate two times a day by mouth starting 7 days before surgery.
The second group will start taking imatinib mesylate 5 days before surgery. Participants
in the third group will begin taking imatinib mesylate 3 days before surgery. After your
surgery, the removed tumor will be studied and compared to the tissue collected before
surgery to see what effect (if any) imatinib mesylate had on the tumor. All patients will
then continue imatinib mesylate for 2 years after surgery.
You will take imatinib mesylate two times a day for 2 years.
If you develop any side effects to the study drug, treatment may be temporarily stopped or
the dose of the drug changed until the symptoms are gone. If the disease gets worse or you
experience any intolerable side effects, you will be taken off the study and your doctor
will discuss other treatment options with you.
You will be seen by a physician regularly after surgery. Two to three tablespoons of blood
will be collected once a month for routine tests, and a you will have a CT scan done every 3
months. These tests will help us determine if your cancer has come back.
THIS IS AN INVESTIGATIONAL STUDY. Imatinib mesylate is FDA approved and is commercially
available. Up to 48 participants will take part in this study. All will be enrolled at M.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival (DFS) time
Effect of drug imatinib mesylate on gastrointestinal stromal tumors (GIST) by disease-free survival (DFS) time, measured from the start of Gleevec therapy, among the three arms to disease progression or 2 years postoperative therapy, measured in months.
Baseline start of therapy to 2 years postoperative Gleevec or disease progression.
Jonathan Trent, MD, PhD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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