Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194753
Status:
COMPLETED
Last Update Posted:
2012-09-13
First Post:
2005-09-14
Brief Title:
Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin Oral Cytoxan With G-CSF for 12 Wks Wkly Taxol x 12
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Adjuvant Therapy for High-Risk Localized Breast Cancer With Weekly Adriamycin - Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Taxol for 12 Weeks Phase II
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:
The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination We hypothesize metronomic dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic dose dense manner
Detailed Description:
The systemic cancer treatments used in this study Adriamycin Cytoxan and Taxol are all delivered in a dose dense metronomic manner weekly or daily It is our hypothesis that dose dense treatment will result in optimum delivered dose intensity while minimizing toxicity We will test these hypotheses by comparing the delivered dose intensity of the drugs to the delivered dose intensity of standard regimens We will also compare time to relapse survival and toxicity of this treatment to historic standard regimens
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 |
|---|---|---|---|
| 00-5889-A 07 | OTHER | UW Human Subjects Division | None |