Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003035
Status:
COMPLETED
Last Update Posted:
2011-03-24
First Post:
1999-11-01
Brief Title:
Doxorubicin and Paclitaxel in Treating Women With Locally Advanced Breast Cancer
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Pilot Trial Comparing Doxorubicin and Paclitaxel Induced Apoptosis in Locally Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2006-12
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 and giving the drugs in different ways may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of doxorubicin with paclitaxel in treating women who have locally advanced breast cancer
PURPOSE Randomized phase II trial to compare the effectiveness of doxorubicin with paclitaxel in treating women who have locally advanced breast cancer
Detailed Description:
OBJECTIVES I Assess the feasibility of obtaining serial biopsies in patients receiving neoadjuvant chemotherapy for locally advanced breast cancer II Assess the feasibility of performing assays of apoptosis and of markers that predict response on specimens obtained in these patients III Correlate the results of the assays with clinical and pathologic response rates IV Establish a baseline of change in apoptosis rates for future studies V Obtain serial blood samples and tumor tissue for future biological studies
OUTLINE This is a randomized study Patients are stratified by pre or postmenopausal state and T3 or T4 lesions Arm I Patients receive single agent doxorubicin by bolus infusion on day 1 Dose repeats every 14 days for a total of four courses provided absolute neutrophil count ANC and platelet count remain in the appropriate range Patients then receive paclitaxel IV administered over 3 hours once every 14 days for a total of four courses provided ANC and platelet count remain in the appropriate range Filgrastim G-CSF subcutaneous treatment is started on day 3 of each course and continued for 7 days or until ANC is greater than 10000mm3 Patients undergo serial core-needle breast biopsies or fine needle aspirations prior to starting therapy and on day one of each course Arm II Patients receive four courses of paclitaxel given once every 14 days Patients then receive four courses of doxorubicin given on day 1 every 14 days provided ANC and platelet count are in the appropriate range G-CSF subcutaneous treatment is started on day 3 of each course as in Arm I Patients undergo serial core-needle breast biopsies or fine needle aspirations prior to starting and on day one of each course Arm I and II Upon completion of eight courses of chemotherapy patients undergo a surgical procedure to evaluate the extent of residual disease and number of lymph nodes involved and to achieve local control Following surgery patients receive additional treatment at the discretion of the treating oncologist Eligible patients undergo further high dose chemotherapy with peripheral blood stem cell rescue other patients receive cyclophosphamide therapy Patients receiving lumpectomies receive breast irradiation Patients receiving mastectomies might receive chest wall irradiation Following radiotherapy hormone receptor positive patients may start tamoxifen therapy for 5 years
PROJECTED ACCRUAL An estimated 40 patients 20 per treatment arm will be accrued for this study
OUTLINE This is a randomized study Patients are stratified by pre or postmenopausal state and T3 or T4 lesions Arm I Patients receive single agent doxorubicin by bolus infusion on day 1 Dose repeats every 14 days for a total of four courses provided absolute neutrophil count ANC and platelet count remain in the appropriate range Patients then receive paclitaxel IV administered over 3 hours once every 14 days for a total of four courses provided ANC and platelet count remain in the appropriate range Filgrastim G-CSF subcutaneous treatment is started on day 3 of each course and continued for 7 days or until ANC is greater than 10000mm3 Patients undergo serial core-needle breast biopsies or fine needle aspirations prior to starting therapy and on day one of each course Arm II Patients receive four courses of paclitaxel given once every 14 days Patients then receive four courses of doxorubicin given on day 1 every 14 days provided ANC and platelet count are in the appropriate range G-CSF subcutaneous treatment is started on day 3 of each course as in Arm I Patients undergo serial core-needle breast biopsies or fine needle aspirations prior to starting and on day one of each course Arm I and II Upon completion of eight courses of chemotherapy patients undergo a surgical procedure to evaluate the extent of residual disease and number of lymph nodes involved and to achieve local control Following surgery patients receive additional treatment at the discretion of the treating oncologist Eligible patients undergo further high dose chemotherapy with peripheral blood stem cell rescue other patients receive cyclophosphamide therapy Patients receiving lumpectomies receive breast irradiation Patients receiving mastectomies might receive chest wall irradiation Following radiotherapy hormone receptor positive patients may start tamoxifen therapy for 5 years
PROJECTED ACCRUAL An estimated 40 patients 20 per treatment arm 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 |
|---|---|---|---|
| P30CA051008 | NIH | None | None |
| GUMC-97018 | None | None | None |
| NCI-V97-1276 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA051008 |