Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028483
Status:
TERMINATED
Last Update Posted:
2011-10-24
First Post:
2002-01-04
Brief Title:
Monoclonal Antibody Therapy and Docetaxel in Treating Women With Metastatic or Recurrent Breast Cancer
Sponsor:
Seagen Inc
Organization:
Seagen Inc
Study Overview
Official Title:
A Phase II Study Using SGN-15 cBR96 - Doxorubicin Immunoconjugate in Combination With Taxotere for the Treatment of Metastatic or Recurrent Breast Carcinoma
Status:
TERMINATED
Status Verified Date:
2011-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 Monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent breast cancer
PURPOSE Phase II trial to study the effectiveness of combining docetaxel and monoclonal antibody therapy in treating women who have metastatic or recurrent breast cancer
Detailed Description:
OBJECTIVES
Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate SGN-15 and docetaxel in women with metastatic or recurrent breast cancer
Determine the clinical response rate and duration of response of patients treated with this regimen
OUTLINE Patients receive doxorubicin-monoclonal antibody BR96 immunoconjugate SGN-15 IV over 2 hours and docetaxel IV over 30 minutes on day 1 of weeks 1-6 Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 18-24 months
Determine the toxicity and safety profile of doxorubicin-monoclonal antibody BR96 immunoconjugate SGN-15 and docetaxel in women with metastatic or recurrent breast cancer
Determine the clinical response rate and duration of response of patients treated with this regimen
OUTLINE Patients receive doxorubicin-monoclonal antibody BR96 immunoconjugate SGN-15 IV over 2 hours and docetaxel IV over 30 minutes on day 1 of weeks 1-6 Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed at 4 weeks
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 18-24 months
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 |
|---|---|---|---|
| UAB-9912 | None | None | None |
| SGEN-UAB-9912 | None | None | None |