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Phase III Randomized, Intergroup Trial Assessing The Clinical Activity Of STI-571 At Two Dose Levels In Patients With Unresectable Or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing The KIT Receptor Tyrosine Kinase (CD117)

Phase 3
15 Years
Open (Enrolling)
Gastrointestinal Stromal Tumor

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Trial Information

Phase III Randomized, Intergroup Trial Assessing The Clinical Activity Of STI-571 At Two Dose Levels In Patients With Unresectable Or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing The KIT Receptor Tyrosine Kinase (CD117)


I. Compare the overall and progression-free survival of patients with CD117-expressing
metastatic or unresectable gastrointestinal stromal tumor treated with two different doses
of imatinib mesylate.

II. Compare the confirmed, unconfirmed, complete, and partial response rates in patients
treated with these regimens.

III. Compare the toxic effects of these regimens in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive oral imatinib mesylate once daily.

Arm II: Patients receive oral imatinib mesylate twice daily.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients in arm I with progressive disease may cross over to arm II and receive treatment in
the absence of further disease progression.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 24 months.

Inclusion Criteria:

- Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST)
which is distantly metastatic or unresectable; tumors must meet BOTH of the following

- The primary must be of visceral or intra-abdominal origin

- All patients must have immunohistochemical documentation of KIT (CD117)
expression by tumor documented by DAKO antibody staining for suggested
methodology) Material must be submitted to the CALGB Pathology Coordinating
Center for pathology review; it is strongly recommended that snap-frozen tissue
biopsy and sera be stored for future submission whenever possible

- Patient must have measurable or non-measurable disease by conventional scan imaging
(CT or MRI) or physical examination; tests used to assess disease must have been
performed within 28 days prior to registration; if a target lesion has been
previously embolized or irradiated, there must be objective evidence of progression
to be considered for response assessment

- Patient must have an identified team (including a medical oncologist and a surgeon)
to provide care

- Patient must not have known brain metastasis

- Patient must have a Zubrod performance status of 0 - 3

- Patient must have resolution of transient toxicities from any prior therapy to =<
grade 1 (NCI-CTC version 2.0)

- The patient must not have received chemotherapy, biologic therapy or any other
investigational drug for any reason within 28 days prior to registration; patients
must not have had a major surgery within 14 days prior to registration

- If day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next
working day

- In calculating days of tests and measurements, the day a test or measurement is
done is considered day 0; therefore, if a test is done on a Monday, the Monday
two weeks later would be considered day 14; this allows for efficient patient
scheduling without exceeding the guidelines

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for 5 years

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal

- At the time of patient registration, the treating institution's name and ID number
must be provided to the Data Operations Center in Seattle in order to ensure that the
current (within 365 days) date of institutional review board approval for this study
has been entered into the data base

- Patients on lower dose arm (Arm 1) will be allowed to increase the daily dose of
STI-571 in the case of disease progression; if there is questionable disease
progression, the treating investigator should contact the primary Study Coordinator,
Dr. George Demetri at 617/632-3985 to review progression information and discuss
treatment options

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall survival (OS)

Outcome Time Frame:

Up to 3 years

Safety Issue:


Principal Investigator

George Demetri

Investigator Role:

Principal Investigator

Investigator Affiliation:

Southwest Oncology Group


United States: Food and Drug Administration

Study ID:




Start Date:

December 2000

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • Gastrointestinal Stromal Tumors



Southwest Oncology Group San Antonio, Texas  78245