Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00429793
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2007-01-30
Brief Title:
Temsirolimus in Treating Patients With Refractory or Recurrent Ovarian Epithelial Fallopian Tube or Primary Peritoneal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of CCI-779 Temsirolimus NCI-Supplied Agent NSC 683864 IND 61010 in the Treatment of Persistent or Recurrent Epithelial Ovarian Fallopian Tube or Primary Peritoneal Carcinoma
Status:
COMPLETED
Status Verified Date:
2019-07
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 is studying the side effects and how well temsirolimus works in treating patients with refractory or recurrent ovarian epithelial cancer fallopian tube cancer or primary peritoneal cancer Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
Detailed Description:
OBJECTIVES Primary I Determine the 6-month progression-free survival PFS or objective tumor response in patients with refractory or recurrent ovarian epithelial fallopian tube or primary peritoneal cavity cancer treated with temsirolimus
II Determine the toxicity of this drug in these patients
Secondary I Determine the duration of PFS and overall survival of these patients
OUTLINE This is a nonrandomized multicenter study
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 every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study
II Determine the toxicity of this drug in these patients
Secondary I Determine the duration of PFS and overall survival of these patients
OUTLINE This is a nonrandomized multicenter study
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 every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 52 patients will be accrued for this study
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-2012-02707 | REGISTRY | None | None |
| CDR0000528257 | None | None | None |
| GOG-0170I | OTHER | None | None |
| GOG-0170I | OTHER | None | None |
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |