Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
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|ClinicalTrials.gov Identifier: NCT00009906|
Recruitment Status : Terminated
First Posted : February 3, 2004
Last Update Posted : December 23, 2014
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Stromal Tumor||Drug: Imatinib Mesylate||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||748 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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)|
|Study Start Date :||December 2000|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||November 2014|
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
- Overall survival (OS) [ Time Frame: Up to 3 years ]
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00009906
|Principal Investigator:||George Demetri||Southwest Oncology Group|