Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005597
Status:
COMPLETED
Last Update Posted:
2013-01-03
First Post:
2000-05-02
Brief Title:
S9926 Temozolomide in Patients With UnresectableMetastatic Gastrointestinal Stromal Tumors
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Study of Temozolomide in Unresectable or Metastatic Gastrointestinal Stromal Tumors GIST
Status:
COMPLETED
Status Verified Date:
2013-01
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors
PURPOSE Phase II trial to study the effectiveness of temozolomide in treating patients who have unresectable or metastatic gastrointestinal stromal tumors
Detailed Description:
OBJECTIVES
Determine the complete and partial response confirmed and unconfirmed in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide
Determine the qualitative or quantitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Patients achieving a confirmed complete response CR receive 2 additional courses after a confirmed CR
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 13-27 months
Determine the complete and partial response confirmed and unconfirmed in patients with unresectable or metastatic gastrointestinal stromal tumors treated with temozolomide
Determine the qualitative or quantitative toxic effects of this regimen in these patients
OUTLINE This is a multicenter study
Patients receive oral temozolomide once daily on days 1-5 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity Patients achieving a confirmed complete response CR receive 2 additional courses after a confirmed CR
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 13-27 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9926 | OTHER | None | None |