Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194740
Status:
COMPLETED
Last Update Posted:
2007-12-06
First Post:
2005-09-14
Brief Title:
Taxotere Plus Weekly Navelbine and G-CSF A Study in Stage IV Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Taxotere Plus Weekly Navelbine and G-CSF A Phase II Study in Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2007-12
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:
The two drugs used to treat metastatic breast cancer in this study may perform better when used together than when used separately The use of another drug that prevents the most common side effect of the two-drug combination permits the delivery of both agents at closer to the full dose for either when used alone We hypothesize that the two-drug combination used with G-CSF support will be more effective and less toxic than other standard regimens for the treatment of metastatic breast cancer
Detailed Description:
Preclinical data suggest that there may be synergy between vinorelbine and paclitaxel when the two drugs are used in combination such that the effect of the two together may be better than either alone Clinical data suggest that the use of concurrent G-CSF with paclitaxel and vinorelbine permits the delivery of both agents at approximately 70 of the full dose for either used alone without G-CSF support with myelosuppression as the usual dose-limiting toxicity and no unusual or unexpected complications Encouragingly 820 40 patients had objective responses with three complete remissions 15 in this program of third-line therapy Therefore we now propose to combine docetaxel at about 70 of full dose with vinorelbine at 275 mgm2 the phase II dose defined in the previous trial Docetaxel will be given on day 1 followed by vinorelbine on days 8 and 15 with G-CSF to be administered on all days except that of docetaxel administration The cycle is to be repeated every three weeks
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