Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00468585
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2007-05-02
Brief Title:
Study of Biweekly Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Multicenter Phase III Study of Every Other Week Capecitabine Dosing With Bevacizumab for the Treatment of Metastatic Breast Cancer Based Upon the Norton-Simon Mathematical Model
Status:
COMPLETED
Status Verified Date:
2015-12
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 purpose of this study is to find out what effects both good and bad that capecitabine has on you and your breast cancer when given in a novel schedule in combination with the antibody therapy bevacizumab Capecitabine Xeloda is an anticancer drug that was approved by FDA in 1998 for treating metastatic breast cancer Capecitabine is a pill that blocks the way cancer cells multiply and grow Usually this medicine is taken twice a day for fourteen days in a row
Patients then get a break from the drug for seven days With this schedule and usual dose some patients on capecitabine have experienced side effects that interfered with their daily comfortDifferent doses and schedules of capecitabine have been studied in animal studies and in people with colon cancer Mathematic modeling has been used to better understand these resultsInformation from these experiments leads us to ask if 7 days of treatment with capecitabine followed by a 7-day break is both safer and more active against breast cancer The study you are considering is a first step in this direction and is designed to demonstrate both safety and activity
Bevacizumab is a biologic therapy that targets the growth of blood vessels which tumors need to grow Women whose breast cancer spread to other parts of their bodies lived longer without their cancers growing when they were treated with bevacizumab and chemotherapy Bevacizumab was tested with the 14-day7-day schedule of capecitabine These two medicines are safe when given together and seem to work better against breast cancer than capecitabine alone
This study is designed to answer the questions
1 What are the side effects of bevacizumab and capecitabine when given in this different schedule and how often do they occur
2 When given in this schedule does capecitabine with bevacizumab help treat breast cancer that has spread or continues to grow despite being treated by other chemotherapy drugs before
Patients then get a break from the drug for seven days With this schedule and usual dose some patients on capecitabine have experienced side effects that interfered with their daily comfortDifferent doses and schedules of capecitabine have been studied in animal studies and in people with colon cancer Mathematic modeling has been used to better understand these resultsInformation from these experiments leads us to ask if 7 days of treatment with capecitabine followed by a 7-day break is both safer and more active against breast cancer The study you are considering is a first step in this direction and is designed to demonstrate both safety and activity
Bevacizumab is a biologic therapy that targets the growth of blood vessels which tumors need to grow Women whose breast cancer spread to other parts of their bodies lived longer without their cancers growing when they were treated with bevacizumab and chemotherapy Bevacizumab was tested with the 14-day7-day schedule of capecitabine These two medicines are safe when given together and seem to work better against breast cancer than capecitabine alone
This study is designed to answer the questions
1 What are the side effects of bevacizumab and capecitabine when given in this different schedule and how often do they occur
2 When given in this schedule does capecitabine with bevacizumab help treat breast cancer that has spread or continues to grow despite being treated by other chemotherapy drugs before
Detailed Description:
A Primary Objectives
To estimate the efficacy of every other week capecitabine and bevacizumab in patients with metastatic breast cancer in terms of overall response rate complete response CR partial response PR when administered at the MTD of capecitabine determined by the phase I portion of this trial
B Secondary Objectives
To estimate secondary efficacy endpoints of this combination including clinical benefit CRPRSD 6 months time to tumor progression TTP progression free survival TTP and duration of response
To evaluate toxicity rates associated with this capecitabine schedule in combination with bevacizumab using the NCI CTC version 3 and the Hand-Foot Syndrome Grading Scale developed by Roche Laboratories Inc
To evaluate the pharmacogenetics of capecitabine in breast cancer patients by assessing the impact of specific candidate SNPs on toxicity andor response
To estimate the efficacy of every other week capecitabine and bevacizumab in patients with metastatic breast cancer in terms of overall response rate complete response CR partial response PR when administered at the MTD of capecitabine determined by the phase I portion of this trial
B Secondary Objectives
To estimate secondary efficacy endpoints of this combination including clinical benefit CRPRSD 6 months time to tumor progression TTP progression free survival TTP and duration of response
To evaluate toxicity rates associated with this capecitabine schedule in combination with bevacizumab using the NCI CTC version 3 and the Hand-Foot Syndrome Grading Scale developed by Roche Laboratories Inc
To evaluate the pharmacogenetics of capecitabine in breast cancer patients by assessing the impact of specific candidate SNPs on toxicity andor response
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