Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407888
Status:
COMPLETED
Last Update Posted:
2017-08-31
First Post:
2006-12-04
Brief Title:
Doxorubicin Hydrochloride Cyclophosphamide and Filgrastim Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation With or Without Trastuzumab in Treating Patients With Breast Cancer Previously Treated With Surgery
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Adjuvant Therapy for High-Risk Localized Breast Cancer Using Weekly Adriamycin Daily Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Abraxane for 12 Weeks With Concurrent Herceptin for Subjects With HER-2Neu Positive Disease Phase II
Status:
COMPLETED
Status Verified Date:
2017-08
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 such as doxorubicin hydrochloride cyclophosphamide and paclitaxel albumin-stabilized nanoparticle formulation work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Monoclonal antibodies such as trastuzumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Giving combination chemotherapy and filgrastim together with trastuzumab may kill more tumor cells
PURPOSE This phase II trial is studying how well giving doxorubicin hydrochloride cyclophosphamide and filgrastim together followed by paclitaxel albumin-stabilized nanoparticle formulation and trastuzumab works in treating patients with breast cancer previously treated with surgery
PURPOSE This phase II trial is studying how well giving doxorubicin hydrochloride cyclophosphamide and filgrastim together followed by paclitaxel albumin-stabilized nanoparticle formulation and trastuzumab works in treating patients with breast cancer previously treated with surgery
Detailed Description:
PRIMARY OBJECTIVES
I To assess disease-free survival following a dose-intensive weekly regimen of Adriamycin oral cyclophosphamide augmented with G-CSF support followed by Abraxane and Herceptin if appropriate for adjuvant treatment of high risk breast cancer patients
SECONDARY OBJECTIVES
I To assess the toxicity associated with this regimen II To assess the delivered dose intensity of the regimen III To assess time to treatment failure and overall survival of the regimen IV To assess the incidence and severity of delayed nausea and vomiting with this regimen
OUTLINE
Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1 oral cyclophosphamide once daily on days 1-7 and filgrastim subcutaneously on days 2-7 Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity Beginning 1 week later patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity Patients with HER-2neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 2 years and then annually thereafter
I To assess disease-free survival following a dose-intensive weekly regimen of Adriamycin oral cyclophosphamide augmented with G-CSF support followed by Abraxane and Herceptin if appropriate for adjuvant treatment of high risk breast cancer patients
SECONDARY OBJECTIVES
I To assess the toxicity associated with this regimen II To assess the delivered dose intensity of the regimen III To assess time to treatment failure and overall survival of the regimen IV To assess the incidence and severity of delayed nausea and vomiting with this regimen
OUTLINE
Patients receive dose-intensive chemotherapy comprising doxorubicin hydrochloride IV over 10-15 minutes on day 1 oral cyclophosphamide once daily on days 1-7 and filgrastim subcutaneously on days 2-7 Courses repeat every 7 days for up to 12 weeks in the absence of disease progression or unacceptable toxicity Beginning 1 week later patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes once a week for 12 weeks in the absence of disease progression or unacceptable toxicity Patients with HER-2neu positive disease also receive trastuzumab IV over 30-90 minutes once a week for 1 year in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 2 years every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| NCI-2010-02117 | REGISTRY | CTRP Clinical Trial Reporting Program | None |