Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075647
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2004-01-09
Brief Title:
CCI-779 in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of CCI-779 in Locally Advanced or Metastatic Pancreatic Cancer
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:
Drugs used in chemotherapy such as CCI-779 work in different ways to stop tumor cells from dividing so they stop growing or die This phase II trial is studying how well CCI-779 works in treating patients with locally advanced or metastatic pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779
SECONDARY OBJECTIVES
I Determine time to progression progression-free survival overall survival and tumor response rate in patients with measurable disease treated with this drug
II Correlate biomarkers of response with clinical response in patients treated with this drug
III Determine the safety and toxicity of this drug in these patients
OUTLINE This is an open-label study
Patients receive CCI-779 IV over 30 minutes once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 13 months
I Determine the overall survival at 6 months in patients with locally advanced or metastatic pancreatic cancer treated with CCI-779
SECONDARY OBJECTIVES
I Determine time to progression progression-free survival overall survival and tumor response rate in patients with measurable disease treated with this drug
II Correlate biomarkers of response with clinical response in patients treated with this drug
III Determine the safety and toxicity of this drug in these patients
OUTLINE This is an open-label study
Patients receive CCI-779 IV over 30 minutes once weekly Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 13 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 |
|---|---|---|---|
| CDR0000347405 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM17003 |
| MDA-2003-0530 | None | None | None |
| N01CM17003 | NIH | None | None |