Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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)|
- Overall survival (OS) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From date of registration to date of first observation of progressive disease or death due to any cause, assessed up to 3 years ] [ Designated as safety issue: No ]
- Toxicity defined as any grade 3 or greater organ toxicity, or any grade 4 or greater hematological toxicity as assessed by CTCAE version 2.0 [ Time Frame: Up to 3 year after completion of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2000|
|Estimated Primary Completion Date:||April 2026 (Final data collection date for primary outcome measure)|
Experimental: Arm I (imatinib mesylate)
Patients receive oral imatinib mesylate once daily.
Drug: imatinib mesylate
Experimental: Arm II (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily.
Drug: imatinib mesylate
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.
|United States, Texas|
|Southwest Oncology Group|
|San Antonio, Texas, United States, 78245|
|Principal Investigator:||George Demetri||Southwest Oncology Group|