Imatinib Mesylate in Treating Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumor
|ClinicalTrials.gov Identifier: NCT00685828|
Recruitment Status : Unknown
Verified July 2014 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was: Active, not recruiting
First Posted : May 28, 2008
Last Update Posted : July 4, 2014
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known which dose of imatinib mesylate is more effective in treating gastrointestinal stromal tumor.
PURPOSE: This randomized phase III trial is studying two different doses of imatinib mesylate to compare how well they work in treating patients with unresectable or metastatic gastrointestinal stromal tumor.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Drug: imatinib mesylate||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||946 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||January 2001|
|Actual Primary Completion Date :||February 2002|
Active Comparator: Arm I
Patients receive low-dose oral imatinib mesylate once daily in the absence of disease progression or unacceptable toxicity.
Drug: imatinib mesylate
Experimental: Arm II
Patients receive high-dose oral imatinib mesylate twice daily in the absence of disease progression or unacceptable toxicity.
Drug: imatinib mesylate
- Progression-free survival
- Overall survival
- Objective tumor response
- Toxicity as assessed by NCI CTC v2.0
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685828
|Study Chair:||Jacob Verweij, MD, PhD||Daniel Den Hoed Cancer Center at Erasmus Medical Center|
|Study Chair:||Paolo G. Casali, MD||Fondazione IRCCS Istituto Nazionale dei Tumori, Milano|
|Study Chair:||John R. Zalcberg, MB, BS, PhD, FRACP||Peter MacCallum Cancer Centre, Australia|
|Study Chair:||Kirsten Sundby Hall, MD||Lund University Hospital|