Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121134
Status:
COMPLETED
Last Update Posted:
2013-12-24
First Post:
2005-07-13
Brief Title:
Bevacizumab With or Without Cyclophosphamide and Methotrexate A Pilot Study in Women With Operable Breast Cancer
Sponsor:
Harold J Burstein MD PhD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Anti-Angiogenesis Treatment After Preoperative Chemotherapy A Pilot Study in Women With Operable Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-11
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 purpose of this research study is to study the effects good and bad of bevacizumab alone bevacizumab with low-dose continuous chemotherapy called metronomic chemotherapy or bevacizumab with capecitabine on you and your cancer The goals of the study will be to
Examine the safety of these drugs
See how easy or difficult it is to be treated with them
Monitor for any signs of recurrent cancer
Look at blood markers that might indicate how the treatment is working
Examine the safety of these drugs
See how easy or difficult it is to be treated with them
Monitor for any signs of recurrent cancer
Look at blood markers that might indicate how the treatment is working
Detailed Description:
This study is broken into 4 groups A B C and D Enrollment closed to all groups in May 2008
The first forty subjects Group A in this study were treated with Bevacizumab only which is given through a vein over 1-2 hours every 3 weeks for a total of approximately 12 months 17 cycles Each cycle consists of 3 weeks
The next forty subjects Group B were treated with Bevacizumab and metronomic CM chemotherapy These subjects took cyclophosphamide 1 pill by mouth every day methotrexate 1 pill taken by mouth twice a day for the first two days of each week and Bevacizumab once every 3 weeks The treatments with cyclophosphamide methotrexate and Bevacizumab will continue for approximately 6 months 8 cycles Then for the next 6 months they received Bevacizumab treatments only The total time on this study will be about 12 months 17 cycles
The next forty subjects Group C were treated with Bevacizumab and Capecitabine chemotherapy These subjects took Capecitabine pills twice a day for 14 days then one week of rest to complete a 21-day cycle There will be a total of 6 cycles of Capecitabine meaning 18 weeks of treatment with both Capecitabine and Bevacizumab Then received Bevacizumab treatments only 11 cycles to complete 12 months of therapy Total duration of your treatment will be about 12 months or 17 cycles of therapy
The last forty subjects Group D are being treated with Bevacizumab and Capecitabine chemotherapy on a different schedule These subjects will take Capecitabine pills twice a day for 7 days then one week of rest and repeat this for a total of 24 weeks 6 cycles Each cycle will last for 4 weeks 28 days There will be a total of 6 cycles of Capecitabine meaning 24 weeks of treatment with both Capecitabine and Bevacizumab Bevacizumab will be given every two weeks for a total of 24 weeks 6 cycles Then they will receive Bevacizumab treatments only every 3 weeks for additional 27 weeks 9 cycles to complete 12 months of therapy For the last 9 cycles of Bevacizumab therapy each cycle will consist of 3 weeks Total duration of treatment will be about 12 months or 15 cycles of therapy
The first forty subjects Group A in this study were treated with Bevacizumab only which is given through a vein over 1-2 hours every 3 weeks for a total of approximately 12 months 17 cycles Each cycle consists of 3 weeks
The next forty subjects Group B were treated with Bevacizumab and metronomic CM chemotherapy These subjects took cyclophosphamide 1 pill by mouth every day methotrexate 1 pill taken by mouth twice a day for the first two days of each week and Bevacizumab once every 3 weeks The treatments with cyclophosphamide methotrexate and Bevacizumab will continue for approximately 6 months 8 cycles Then for the next 6 months they received Bevacizumab treatments only The total time on this study will be about 12 months 17 cycles
The next forty subjects Group C were treated with Bevacizumab and Capecitabine chemotherapy These subjects took Capecitabine pills twice a day for 14 days then one week of rest to complete a 21-day cycle There will be a total of 6 cycles of Capecitabine meaning 18 weeks of treatment with both Capecitabine and Bevacizumab Then received Bevacizumab treatments only 11 cycles to complete 12 months of therapy Total duration of your treatment will be about 12 months or 17 cycles of therapy
The last forty subjects Group D are being treated with Bevacizumab and Capecitabine chemotherapy on a different schedule These subjects will take Capecitabine pills twice a day for 7 days then one week of rest and repeat this for a total of 24 weeks 6 cycles Each cycle will last for 4 weeks 28 days There will be a total of 6 cycles of Capecitabine meaning 24 weeks of treatment with both Capecitabine and Bevacizumab Bevacizumab will be given every two weeks for a total of 24 weeks 6 cycles Then they will receive Bevacizumab treatments only every 3 weeks for additional 27 weeks 9 cycles to complete 12 months of therapy For the last 9 cycles of Bevacizumab therapy each cycle will consist of 3 weeks Total duration of treatment will be about 12 months or 15 cycles of therapy
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