Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041470
Status:
TERMINATED
Last Update Posted:
2017-07-17
First Post:
2002-07-09
Brief Title:
Navelbine Taxol Herceptin and Neupogen in Stage IV Breast Cancer A Phase I - II Trial
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Navelbine Taxol Herceptin and Neupogen in Stage IV Breast Cancer A Phase I - II Trial
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor withdrew the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purposes of this are
To determine the highest doses of Taxol and Navelbine that we can safely give to patients
To determine what kind of side effects are caused by the combination of Taxol Navelbine and G-CSF
To determine whether the combination of Taxol Navelbine and G-CSF is more effective than standard therapy in treating metastatic breast cancer and prolonging life
To determine the highest doses of Taxol and Navelbine that we can safely give to patients
To determine what kind of side effects are caused by the combination of Taxol Navelbine and G-CSF
To determine whether the combination of Taxol Navelbine and G-CSF is more effective than standard therapy in treating metastatic breast cancer and prolonging life
Detailed Description:
Complete response CR in advanced breast cancer is an important predictor of improved survival The largest experience reported with long-term follow-up in this regard is from MD Anderson Hospital with a median survival of 33 months and 5-year survival of 19 among patients who achieved a CR with doxorubicin-based chemotherapy19 We believe that our institutional experience to date indicates that CR rates in excess of 20 can be achieved in second-line chemotherapy from the combination of vinorelbine and a taxane provided that G-CSF is given For the reasons outlined we believe that dose density is likely to be important for both classes of agents but dose intensity may be most important for vinorelbine Both paclitaxel and docetaxel can be given on a weekly schedule with some success but it appears that myelosuppression is a more frequent dose-limiting toxicity on this schedule for docetaxel For the current trial we therefore propose to study weekly paclitaxel in combination with dose-intensive vinorelbine utilizing continuous G-CSF support as in our prior studies We believe that starting doses of 60 mgm2 for paclitaxel and 20 mgm2 for vinorelbine will be well tolerated but our experience to date treating 3 patients off study at these doses without G-CSF support indicates that some will require G-CSF even at this dose level we observed grade 4 neutropenia in 2 of the 3 Our intention in this trial is to determine the optimal dose of these two agents when continuous growth factor support is provided We will be starting at a ratio of 08 for vinorelbine and 075 for paclitaxel assuming 80 mgm2week as a full dose for the later agent
It is now widely appreciated that patients with metastatic breast cancer whose tumors over express HER-2-neu demonstrate benefit from the addition of trastuzumab Herceptin to a chemotherapy program with paclitaxel as a single agent20 Such patients will be allowed to receive trastuzumab in the standard dose and schedule 4 mgkg loading dose then 2 mgkgweek given IV in addition to paclitaxel and vinorelbine Since trastuzumab does not produce myelosuppression or neuropathy the anticipated dose-limiting toxicities for vinorelbine and paclitaxel respectively and neither of these agents combined separately with trastuzumab produces unusual or severe new side effects this should not affect the dose escalation scheme for the chemotherapeutic agents
It is now widely appreciated that patients with metastatic breast cancer whose tumors over express HER-2-neu demonstrate benefit from the addition of trastuzumab Herceptin to a chemotherapy program with paclitaxel as a single agent20 Such patients will be allowed to receive trastuzumab in the standard dose and schedule 4 mgkg loading dose then 2 mgkgweek given IV in addition to paclitaxel and vinorelbine Since trastuzumab does not produce myelosuppression or neuropathy the anticipated dose-limiting toxicities for vinorelbine and paclitaxel respectively and neither of these agents combined separately with trastuzumab produces unusual or severe new side effects this should not affect the dose escalation scheme for the chemotherapeutic agents
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