Ignite Creation Date:
2024-05-05 @ 4:52 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331682
Status:
COMPLETED
Last Update Posted:
2014-05-28
First Post:
2006-05-30
Brief Title:
Docetaxel and Flavopiridol in Treating Patients With Refractory Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open-Label Non-Randomized Phase II Study of Alvocidib Flavopiridol in Combination With Docetaxel in Refractory Metastatic Pancreatic Cancer NCI 6366
Status:
COMPLETED
Status Verified Date:
2013-11
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 docetaxel and flavopiridol work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Flavopiridol may also help docetaxel work better by making tumor cells more sensitive to the drug This phase II trial is studying how well giving docetaxel followed by flavopiridol works in treating patients with refractory metastatic pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the response rate in patients with refractory metastatic pancreatic cancer treated with weekly sequential docetaxel and flavopiridol
SECONDARY OBJECTIVES
I Determine the time to progression and overall survival of patients treated with this regimen
II Assess the toxicity of this regimen
OUTLINE This is a non-randomized open-label prospective study
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
I Determine the response rate in patients with refractory metastatic pancreatic cancer treated with weekly sequential docetaxel and flavopiridol
SECONDARY OBJECTIVES
I Determine the time to progression and overall survival of patients treated with this regimen
II Assess the toxicity of this regimen
OUTLINE This is a non-randomized open-label prospective study
Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| R01CA067819 | NIH | None | httpsreporternihgovquickSearchR01CA067819 |
| 05-136 | None | None | None |
| MSKCC-05136 | None | None | None |
| NCI-6366 | None | None | None |
| CDR0000472413 | None | None | None |