Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087282
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2004-07-08
Brief Title:
Irinotecan and Flavopiridol in Treating Patients With Advanced Liver Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Non-Randomized Phase II Study of Sequential Irinotecan CPT-11 And Flavopiridol In Patients With Advanced Hepatoma
Status:
COMPLETED
Status Verified Date:
2005-05
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:
RATIONALE Drugs used in chemotherapy such as irinotecan and flavopiridol work in different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE This phase II trial is studying how well giving irinotecan together with flavopiridol works in treating patients with advanced liver cancer
PURPOSE This phase II trial is studying how well giving irinotecan together with flavopiridol works in treating patients with advanced liver cancer
Detailed Description:
OBJECTIVES
Primary
Determine the time to progression in patients with advanced hepatocellular carcinoma treated with irinotecan and flavopiridol
Secondary
Determine the response rate and overall survival in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label non-randomized study
Patients receive irinotecan IV over 30 minutes and flavopiridol IV over 1 hour on days 1 8 15 and 22 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 16-32 patients will be accrued for this study within 2 years
Primary
Determine the time to progression in patients with advanced hepatocellular carcinoma treated with irinotecan and flavopiridol
Secondary
Determine the response rate and overall survival in patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is an open-label non-randomized study
Patients receive irinotecan IV over 30 minutes and flavopiridol IV over 1 hour on days 1 8 15 and 22 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 16-32 patients will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-6475 | None | None | None |
| MSKCC-04038 | None | None | None |