Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 9:09 AM
Study NCT ID:
NCT00020332
Status:
COMPLETED
Last Update Posted:
2013-06-17
First Post:
2001-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Docetaxel and Flavopiridol in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase I/II 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 I/II trial to study the effectiveness of combination chemotherapy in treating patients who have locally advanced or metastatic breast cancer.
PURPOSE: Phase I/II 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 activation/memory subsets and natural killer cell/lymphokine-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 activation/memory subsets and natural killer cell/lymphokine-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?: