Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-26 @ 8:36 PM
Study NCT ID:
NCT01026792
Status:
COMPLETED
Last Update Posted:
2015-09-10
First Post:
2009-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Temsirolimus in Treating Patients With Cervical Cancer That Is Recurrent, Locally Advanced, Metastatic, or Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study of Temsirolimus (NSC 683864), an mTOR Inhibitor, in Patients With Recurrent, Unresectable, Locally Advanced or Metastatic Carcinoma of the Cervix
Status:
COMPLETED
Status Verified Date:
2014-02
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 the effects of temsirolimus in treating patients with cervical cancer that cannot be cured by standard therapy. Temsirolimus interferes with a protein in cells that is part of one pathway that sends signals to stimulate cell growth and survival. By blocking this protein cancer cells may stop growing or die.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the efficacy (objective response rate) of temsirolimus given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.
II. To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.
III. To explore the relationship between expression of proteins in the mammalian target of rapamycin (mTOR) pathway in archival tissue samples from patients on this trial and their objective response to therapy.
OUTLINE:
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses 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 (patients with complete response \[CR\], partial response \[PR\], or stable disease \[SD\] only) thereafter.
I. To assess the efficacy (objective response rate) of temsirolimus given intravenously (IV) weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.
II. To assess the adverse events, time to progression and response duration of temsirolimus given IV weekly in patients with metastatic and/or locally advanced recurrent carcinoma of the cervix.
III. To explore the relationship between expression of proteins in the mammalian target of rapamycin (mTOR) pathway in archival tissue samples from patients on this trial and their objective response to therapy.
OUTLINE:
Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses 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 (patients with complete response \[CR\], partial response \[PR\], or stable disease \[SD\] only) thereafter.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-00268 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| NCIC-CTG-199 | None | None | View | |
| CDR0000660702 | None | None | View | |
| IND.199 | None | None | View | |
| CAN-NCIC-IND199 | None | None | View | |
| NCIC-199 | OTHER | National Cancer Institute of Canada Clinical Trials Group | View | |
| NCIC-199 | OTHER | CTEP | View |