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| Sponsor: | European Organization for Research and Treatment of Cancer - EORTC |
|---|---|
| Collaborators: |
Italian Sarcoma Group Australasian Gastro-Intestinal Trials Group Scandinavian Sarcoma Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00685828 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Treatment |
| 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) |
| Estimated Enrollment: | 600 |
| Study Start Date: | January 2001 |
| Arms | Assigned Interventions |
|---|---|
|
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
By mouth
|
|
Experimental: Arm II
Patients receive high-dose oral imatinib mesylate twice daily in the absence of disease progression or unacceptable toxicity.
|
Drug: imatinib mesylate
By mouth
|
OBJECTIVES:
Primary
Secondary
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastrointestinal stromal tumor (GIST)
Measurable or non-measurable disease by conventional imaging (CT scan or MRI) or physical examination
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent therapeutic anticoagulation with coumarin derivatives
Contacts and Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00685828 History of Changes |
| Other Study ID Numbers: | CDR0000596490, EORTC-62005, AGITG-AGO102-GIST, ISG-62005, SSG-15 |
| Study First Received: | May 22, 2008 |
| Last Updated: | July 24, 2009 |
| Health Authority: | United States: Federal Government |
|
gastrointestinal stromal tumor |
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |