Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020332
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2001-07-11
Brief Title:
Docetaxel and Flavopiridol in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of Docetaxel Followed by Infusional Flavopiridol Over 72 Hours in Patients With Previously Treated Locally Advanced or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2002-07
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 tumor cells
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of docetaxel and flavopiridol in patients with previously treated locally advanced or metastatic breast cancer
Determine the dose-limiting toxicity toxicity profile and pharmacokinetics of this regimen in these patients
Determine the activity of this regimen in these patients
Determine the objective response rate in patients treated with this regimen
Determine immune dysfunction produced by this regimen as measured by lymphocyte subpopulations including T-cell activationmemory subsets and natural killer celllymphokine-activated killer cell functional subsets in these patients
Determine the ability of positron emission tomography scanning to predict response in patients treated with this regimen
Determine the response duration time to treatment failure and overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine whether this regimen is associated with the development of a prothrombotic state in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 1 hour on day 1 followed by flavopiridol IV over 1 hour or IV continuously on days 2-4 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Sequential dose escalation of docetaxel is preceded or followed by sequential dose escalation of flavopiridol Cohorts of 3-6 patients receive escalating doses of docetaxel preceded or followed by escalating doses of flavopiridol until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 22 additional patients are accrued to receive flavopiridol and docetaxel at the recommended phase II dose
Quality of life is assessed at baseline every 3 courses during study and then at completion of study
PROJECTED ACCRUAL A total of 49 patients 27 for phase I and 22 for phase II will be accrued for this study within 2 years
Determine the maximum tolerated dose of docetaxel and flavopiridol in patients with previously treated locally advanced or metastatic breast cancer
Determine the dose-limiting toxicity toxicity profile and pharmacokinetics of this regimen in these patients
Determine the activity of this regimen in these patients
Determine the objective response rate in patients treated with this regimen
Determine immune dysfunction produced by this regimen as measured by lymphocyte subpopulations including T-cell activationmemory subsets and natural killer celllymphokine-activated killer cell functional subsets in these patients
Determine the ability of positron emission tomography scanning to predict response in patients treated with this regimen
Determine the response duration time to treatment failure and overall survival of patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine whether this regimen is associated with the development of a prothrombotic state in these patients
OUTLINE This is a dose-escalation study
Patients receive docetaxel IV over 1 hour on day 1 followed by flavopiridol IV over 1 hour or IV continuously on days 2-4 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Sequential dose escalation of docetaxel is preceded or followed by sequential dose escalation of flavopiridol Cohorts of 3-6 patients receive escalating doses of docetaxel preceded or followed by escalating doses of flavopiridol until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined 22 additional patients are accrued to receive flavopiridol and docetaxel at the recommended phase II dose
Quality of life is assessed at baseline every 3 courses during study and then at completion of study
PROJECTED ACCRUAL A total of 49 patients 27 for phase I and 22 for phase II 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-952 | None | None | None |
| NCI-00-C-0212 | None | None | None |