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.
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
No
Jacob Verweij, MD, PhD
Study Chair
Daniel Den Hoed Cancer Center at Erasmus Medical Center
United States: Federal Government
CDR0000596490
NCT00685828
January 2001
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