Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006245
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2000-09-11
Brief Title:
Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Flavopiridol and Paclitaxel in Patients With Paclitaxel-Refractory Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2004-04
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of combining flavopiridol and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer that has not responded to previous paclitaxel therapy
PURPOSE Phase II trial to study the effectiveness of combining flavopiridol and paclitaxel in treating patients who have locally advanced or metastatic esophageal cancer that has not responded to previous paclitaxel therapy
Detailed Description:
OBJECTIVES
Determine the response rate in patients with paclitaxel-refractory locally advanced or metastatic esophageal cancer treated with sequential paclitaxel and flavopiridol
Determine the toxicity of this regimen in these patients
Assess the quality of life of patients treated with this regimen
Obtain pharmacokinetic information about this regimen
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours on day 1 and flavopiridol IV continuously over 24 hours on day 2 weekly for 3 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after courses 1 and 2 and then every 2 courses thereafter
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-18 months
Determine the response rate in patients with paclitaxel-refractory locally advanced or metastatic esophageal cancer treated with sequential paclitaxel and flavopiridol
Determine the toxicity of this regimen in these patients
Assess the quality of life of patients treated with this regimen
Obtain pharmacokinetic information about this regimen
OUTLINE This is a multicenter study
Patients receive paclitaxel IV over 3 hours on day 1 and flavopiridol IV continuously over 24 hours on day 2 weekly for 3 weeks Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline after courses 1 and 2 and then every 2 courses thereafter
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 6-18 months
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-1672 | None | None | None |
| MSKCC-00060 | None | None | None |