Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072176
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2003-11-04
Brief Title:
Temsirolimus in Treating Patients With Metastatic or Locally Advanced Recurrent Endometrial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of CCI-779 in Patients With Metastatic andor Locally Advanced Recurrent Endometrial Cancer
Status:
COMPLETED
Status Verified Date:
2014-03
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:
This phase II trial studies how well temsirolimus works in treating patients with endometrial cancer that has spread to other parts of the body or has spread from where it started to nearby tissue or lymph nodes and has come back after a period of time during which the cancer could not be detected Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess the efficacy response rate duration of stable disease of CCI-779 temsirolimus given intravenously IV weekly in patients with metastatic andor locally advanced recurrent carcinoma of the endometrium
II To assess the adverse events time to progression and response duration of CCI-779 given IV weekly in patients with metastatic andor locally advanced recurrent carcinoma of the endometrium
III To correlate objective tumor response with phosphatase and tensin homolog gene PTEN expression in the tumor tissue obtained at diagnosis primary tumor
IV To explore the relationship between objective tumor response with other molecular measures in diagnostic tumor tissue
OUTLINE
Patients receive temsirolimus IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 4 weeks and then every 3 months
I To assess the efficacy response rate duration of stable disease of CCI-779 temsirolimus given intravenously IV weekly in patients with metastatic andor locally advanced recurrent carcinoma of the endometrium
II To assess the adverse events time to progression and response duration of CCI-779 given IV weekly in patients with metastatic andor locally advanced recurrent carcinoma of the endometrium
III To correlate objective tumor response with phosphatase and tensin homolog gene PTEN expression in the tumor tissue obtained at diagnosis primary tumor
IV To explore the relationship between objective tumor response with other molecular measures in diagnostic tumor tissue
OUTLINE
Patients receive temsirolimus IV over 30 minutes on days 1 8 15 and 22 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up at 4 weeks and then every 3 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 |
|---|---|---|---|
| NCI-2014-00649 | REGISTRY | None | None |
| I160 | None | None | None |
| CAN-NCIC-IND160 | None | None | None |
| IND160 | None | None | None |
| CDR0000335543 | None | None | None |
| NCIC-160 | OTHER | None | None |
| NCIC-160 | OTHER | CTEP | None |