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Phase III Randomized, Intergroup, International 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
18 Years
N/A
Open (Enrolling)
Both
Gastrointestinal Stromal Tumor

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Trial Information

Phase III Randomized, Intergroup, International 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)


OBJECTIVES:

Primary

- To compare outcomes of patients with unresectable or metastatic gastrointestinal
stromal tumor that expresses KIT (CD117) treated with low-dose imatinib mesylate vs
high-dose imatinib mesylate.

Secondary

- To assess response rates in patients treated with two different doses of imatinib
mesylate.

- To assess the toxicities of two different doses of imatinib mesylate in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, measurability of disease (measurable vs non-measurable), and WHO performance status
(0-2 vs 3). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive low-dose oral imatinib mesylate once daily in the absence of
disease progression or unacceptable toxicity.

- Arm II: Patients receive high-dose oral imatinib mesylate twice daily in the absence of
disease progression or unacceptable toxicity.

In the event of disease progression, patients on arm I may cross over to arm II and receive
high-dose imatinib mesylate. Patients who continue to progress despite treatment with
high-dose imatinib mesylate are removed from the study.

After completion of study therapy, patients are followed periodically.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed gastrointestinal stromal tumor (GIST)

- Metastatic or unresectable disease

- Immunohistochemical confirmation of KIT (CD117) expression by tumor as documented by
DAKO antibody staining

- Measurable or non-measurable disease by conventional imaging (CT scan or MRI) or
physical examination

- If a target lesion has been previously embolized or irradiated, there must be
objective evidence of progression to be considered for response assessment

- No known brain metastasis

PATIENT CHARACTERISTICS:

- WHO performance status 0-3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN if hepatic metastases are present)

- Creatinine ≤ 1.5 times ULN

- ANC ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL (transfusions allowed)

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for up to 3
months after completion of study therapy

- No NYHA class III-IV cardiac disease

- No congestive heart failure or myocardial infarction within the past 2 months

- No severe and/or uncontrolled concurrent medical disease (e.g., uncontrolled
diabetes, uncontrolled chronic renal or liver disease, or active uncontrolled
infection [e.g., HIV])

- No other prior malignancy except adequately treated basal cell or squamous cell skin
cancer, carcinoma in situ of the cervix, 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

- No medical, psychological, familial, sociological, or geographical condition that, in
the opinion of the investigator, may preclude the patient's ability to tolerate or
complete study treatment, comply with study protocol and follow-up schedule, or give
reliable informed consent

PRIOR CONCURRENT THERAPY:

- Recovered from all prior therapy

- More than 28 days since prior chemotherapy, biologic therapy, or any other
investigational drug

- More than 14 days since prior major surgery

- No concurrent therapeutic anticoagulation with coumarin derivatives

- Concurrent therapeutic anticoagulation with low-molecular weight heparin allowed

- Concurrent mini-dose coumarin derivatives (i.e., equivalent to 1 mg of oral
warfarin daily) as prophylaxis allowed

- No concurrent cytokines (i.e., filgrastim [G-CSF] or sargramostim [GM-CSF]) to
support blood counts

- No other concurrent investigational drugs

- No other concurrent anticancer agents, including chemotherapy, radiotherapy, or
anticancer biologic therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Safety Issue:

No

Principal Investigator

Jacob Verweij, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000596490

NCT ID:

NCT00685828

Start Date:

January 2001

Completion Date:

Related Keywords:

  • Gastrointestinal Stromal Tumor
  • gastrointestinal stromal tumor
  • Gastrointestinal Stromal Tumors

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