Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009906
Status:
TERMINATED
Last Update Posted:
2014-12-23
First Post:
2001-02-02
Brief Title:
Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| N01CM17003 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17003 |
| NCI-2012-02372 | REGISTRY | None | None |
| S0033 | None | None | None |
| INT-S0033 | None | None | None |
| CDR0000068422 | None | None | None |
| CAN-NCIC-S0033 | None | None | None |
| CLB-80004 | None | None | None |
| SWOG-S0033 | None | None | None |
| E-S0033 | None | None | None |
| S0033 | OTHER | None | None |
| S0033 | OTHER | None | None |
| U10CA180888 | NIH | None | None |
| U10CA032102 | NIH | None | None |