Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00088998
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2004-08-04
Brief Title:
Docetaxel Capecitabine and Bevacizumab in Treating Patients With Metastatic Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial Of Docetaxel With Capecitabine And Bevacizumab As First-Line Chemotherapy For Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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:
RATIONALE Drugs used in chemotherapy such as docetaxel and capecitabine work in different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Bevacizumab may also stop the growth of tumor cells by stopping blood flow to the tumor Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer
PURPOSE This phase II trial is studying how well giving docetaxel and capecitabine together with bevacizumab works in treating patients with metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with metastatic breast cancer treated with docetaxel capecitabine and bevacizumab as first-line chemotherapy
Secondary
Determine time to disease progression in patients treated with this regimen
Determine survival of patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
Determine the duration of response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1 Patients also receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive at least 2 additional courses beyond CR
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
Primary
Determine the response rate in patients with metastatic breast cancer treated with docetaxel capecitabine and bevacizumab as first-line chemotherapy
Secondary
Determine time to disease progression in patients treated with this regimen
Determine survival of patients treated with this regimen
Determine the toxicity profile of this regimen in these patients
Determine the duration of response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 1 hour and bevacizumab IV over 30-90 minutes on day 1 Patients also receive oral capecitabine twice daily on days 1-14 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients achieving a complete response CR receive at least 2 additional courses beyond CR
Patients are followed every 3 months for 1 year every 6 months for 1 year and then annually for 3 years
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 |
|---|---|---|---|
| CDR0000377886 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02617 | REGISTRY | None | None |