NCT00009906

Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

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)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 748 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase III trial to compare the effectiveness of two different doses of STI571 in treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571 may interfere with the growth of tumor cells and may be an effective treatment for cancer. It is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal tumors.

Detailed description

PRIMARY OBJECTIVES: 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.

Conditions

• Gastrointestinal Stromal Tumor

Interventions

Type	Name	Description
DRUG	Imatinib Mesylate	Given orally

Timeline

• Start date: 2000-12-01
• Primary completion: 2007-05-01
• Completion: 2014-11-01
• First posted: 2004-02-03
• Last updated: 2014-12-23

Locations

144 sites across 3 countries: United States, Canada, Puerto Rico