Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005800
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2000-06-02
Brief Title:
Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Neoadjuvant Trial of Sequential Doxorubicin and Docetaxel for the Treatment of Stage III Breast Cancer Measuring STAT Activation as a Predictor of Response to Therapy
Status:
COMPLETED
Status Verified Date:
2012-09
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 II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have stage III breast cancer
PURPOSE Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have stage III breast cancer
Detailed Description:
OBJECTIVES
Evaluate the clinical and pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer
Measure signal transducer and activator of transcription STAT activation before and after this neoadjuvant chemotherapy regimen in this patient population
Correlate response to chemotherapy with STAT activation before and after this neoadjuvant chemotherapy regimen in these patients
Determine how other potential predictors of response correlate with STAT activation by measuring Bcl-2 Bcl-xL Bax protein levels tyrosine kinase levels growth rate of the tumor and apoptotic index before and after this neoadjuvant chemotherapy regimen in these patients
Correlate response to chemotherapy with levels of STAT activation in association with the presence of Bcl-2 proteins and tyrosine kinases growth rate of the tumor and apoptotic index in these patients
Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense fashion in these patients
OUTLINE Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses After 3 weeks of rest patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses Filgrastim G-CSF is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course Within 6 weeks of completion of neoadjuvant chemotherapy patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 5 years
Evaluate the clinical and pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer
Measure signal transducer and activator of transcription STAT activation before and after this neoadjuvant chemotherapy regimen in this patient population
Correlate response to chemotherapy with STAT activation before and after this neoadjuvant chemotherapy regimen in these patients
Determine how other potential predictors of response correlate with STAT activation by measuring Bcl-2 Bcl-xL Bax protein levels tyrosine kinase levels growth rate of the tumor and apoptotic index before and after this neoadjuvant chemotherapy regimen in these patients
Correlate response to chemotherapy with levels of STAT activation in association with the presence of Bcl-2 proteins and tyrosine kinases growth rate of the tumor and apoptotic index in these patients
Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense fashion in these patients
OUTLINE Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses After 3 weeks of rest patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses Filgrastim G-CSF is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course Within 6 weeks of completion of neoadjuvant chemotherapy patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection
PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 5 years
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 |
|---|---|---|---|
| CA 82533 | OTHER | NCI | None |