Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093782
Status:
COMPLETED
Last Update Posted:
2017-02-07
First Post:
2004-10-06
Brief Title:
Temsirolimus in Treating Patients With Metastatic Neuroendocrine Carcinoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of CCI-779 in Metastatic Neuroendocrine Carcinomas
Status:
COMPLETED
Status Verified Date:
2016-12
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 how well CCI-779 works in treating patients with progressive metastatic neuroendocrine tumors Drugs used in chemotherapy such as CCI-779 work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I To assess the objective tumor response rate ie partial or complete responses as defined by the RECIST criteria in patients with progressive metastatic neuroendocrine tumours given CCI-779
II To assess the stable disease rate and duration time to progression median survival time 1-year survival rate and toxicity in patients with metastatic neuroendocrine carcinomas given CCI-779 As of 19 July 2010 overall survival follow-up is to be discontinued for the four remaining patients on long term follow-up At that point in time these patients had been off-treatment for 3 to 5 years Time to progression and median survival times will be based on the currently available data
III To measure baseline levels of various elements up- and downstream of the mammalian target of rapamycin mTOR Where post-treatment biopsies are available they will be analyzed for suppression of elements in the mTOR pathway as well as for any effect on cell cycle progression apoptosis or anti-angiogenic effects
OUTLINE This is an open-label multicenter study
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR or partial response PR receive 2 additional courses beyond CR or PR
Patients are followed up for survival
I To assess the objective tumor response rate ie partial or complete responses as defined by the RECIST criteria in patients with progressive metastatic neuroendocrine tumours given CCI-779
II To assess the stable disease rate and duration time to progression median survival time 1-year survival rate and toxicity in patients with metastatic neuroendocrine carcinomas given CCI-779 As of 19 July 2010 overall survival follow-up is to be discontinued for the four remaining patients on long term follow-up At that point in time these patients had been off-treatment for 3 to 5 years Time to progression and median survival times will be based on the currently available data
III To measure baseline levels of various elements up- and downstream of the mammalian target of rapamycin mTOR Where post-treatment biopsies are available they will be analyzed for suppression of elements in the mTOR pathway as well as for any effect on cell cycle progression apoptosis or anti-angiogenic effects
OUTLINE This is an open-label multicenter study
Patients receive CCI-779 IV over 30 minutes on days 1 8 15 and 22 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients who achieve a complete response CR or partial response PR receive 2 additional courses beyond CR or PR
Patients are followed up for survival
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 |
|---|---|---|---|
| PHL-021 | None | None | None |
| 6171 | None | None | None |
| N01CM17105 | NIH | None | None |
| N01CM17107 | NIH | None | None |
| N01CM17102 | NIH | None | httpsreporternihgovquickSearchN01CM17102 |