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)
N/A
N/A
Both
Gastrointestinal Stromal Tumors
Trial Information
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.
D. Anderson.
Inclusion Criteria:
1. Signed informed consent.
2. Patients must have a histologically proven diagnosis of primary, locally advanced
and/or metastatic GIST for which complete or partial resection is planned by a MDACC
sarcoma surgeon.
3. Patients must have immunohistochemical documentation of kit expression in the tumor
using the DAKO A4502 or other acceptable antibody.
4. Patients must have a least one lesion greater than 1 cm that can be accurately
measured in one dimension by plain radiograph, CT or magnetic resonance imaging
(MRI).
5. Patients must have normal organ and marrow function (White blood count-WBC greater
than or equal to 3,000/ul, Absolute neutrophil count (ANC) greater than or equal to
1500/ul, platelets greater than or equal to 100,00/ul, total bilirubin less than or
equal to 1.5 * Upper Limits of Normal (ULN), aspartate aminotransferase (AST or SGOT)
or alanine aminotransferase (ALT or SGPT) less than or equal to 2.5 * ULN, serum
creatinine less than or equal to 1.5 * ULN).
6. Patients must have a serum glucose < 200 mg/dl prior to PET scan. Patients must be
able to lie flat and still for the PET scan.
7. Patients may not have any uncontrolled medical or psychiatric conditions that would
make the patient unable to tolerate therapy. Patients with uncontrolled medical
conditions or psychiatric conditions may have informed consent granted by a legal
guardian or surrogate decision maker.
8. Patients may not have any prior malignancy in the past 5 years other than
non-melanoma skin cancer, cervical cancer in situ, or any other malignancy that is
not currently clinically significant.
9. Zubrod performance status of 0 - 3.
10. May not have metastases outside of the peritoneal cavity.
11. If patients have any signs or symptoms of metastases, the appropriate workup should
occur prior to enrollment (eg, CT of the head for a patient with central nervous
system (CNS) symptoms).
12. Patients may not have had chemotherapy, radiotherapy, biological therapy or any
investigational drugs 3 weeks prior to the study.
13. Women should have a negative pregnancy test within 7 days of study opening.
14. Patients must agree to use an effective contraceptive method.
Exclusion Criteria:
1. Prior treatment using Gleevec.
2. Patients with Class III or Class IV New York Heart Association congestive heart
failure.
3. Pregnant or nursing women.
4. Patients taking therapeutic doses of Coumadin for anticoagulation. Coumadin may be
taken but dose should be less than or equal to 1 mg po per day. Patients MAY take a
low molecular weight heparin.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease-free survival (DFS) time
Outcome Description:
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.
Outcome Time Frame:
Baseline start of therapy to 2 years postoperative Gleevec or disease progression.
Safety Issue:
No
Principal Investigator
Jonathan Trent, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
ID03-0023
NCT ID:
NCT00500188
Start Date:
July 2003
Completion Date:
July 2011
Related Keywords:
- Gastrointestinal Stromal Tumors
- Gastrointestinal Stromal Tumors
- GIST
- Kit expression
- Resectable
- Imatinib Mesylate
- Gleevec
- STI-571
- Imatinib
- NSC-716051
- Gastrointestinal Stromal Tumors
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
