Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00079235
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2004-03-08
Brief Title:
CCI-779 in Treating Patients With Stage IIIB With Pleural Effusion or Stage IV Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of the mTOR Inhibitor CCI-779 in Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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 stage IIIB non small cell lung cancer with pleural effusion or stage IV non-small cell lung cancer Drugs used in chemotherapy such as CCI-779 work in different ways to stop tumor cells from dividing so they stop growing or die CCI-779 may also stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
OBJECTIVES Primary I Determine the response rate in patients with stage IIIB with pleural effusion or IV non-small cell lung cancer treated with CCI-779
II Determine the clinical toxic effects of this drug in these patients
Secondary I Determine the 24-week progression-free survival rate in patients treated with this drug
II Determine the time to progression and overall survival of patients treated with this drug
III Evaluate predictive markers of activity eg PTEN mutations and phosphoAkt expression of this drug in these patients
OUTLINE This is a multicenter study
Patients receive CCI-779 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
Patients are followed every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 25-55 patients will be accrued for this study within 12 months
II Determine the clinical toxic effects of this drug in these patients
Secondary I Determine the 24-week progression-free survival rate in patients treated with this drug
II Determine the time to progression and overall survival of patients treated with this drug
III Evaluate predictive markers of activity eg PTEN mutations and phosphoAkt expression of this drug in these patients
OUTLINE This is a multicenter study
Patients receive CCI-779 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
Patients are followed every 6 months for up to 5 years
PROJECTED ACCRUAL A total of 25-55 patients will be accrued for this study within 12 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 |
|---|---|---|---|
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |
| N0323 | None | None | None |
| CDR0000355117 | None | None | None |
| NCCTG-N0323 | None | None | None |