Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216021
Status:
COMPLETED
Last Update Posted:
2015-12-09
First Post:
2005-09-09
Brief Title:
Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Capecitabine and Oxaliplatin CAPOX in Patients With Metastatic Breast Cancer Hoosier Oncology Group BRE03-60
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:
In vitro data suggest synergy between oxaliplatin and 5-FU The combination of oxaliplatin with 5-fluorouracil produced objective response rates ranging from 27-34 in two studies of patients with prior chemotherapy Capecitabine was designed as an orally administered tumor selective fluoropyrimidine preferentially converted to 5-FU at the tumor site by the higher levels of pyrimidine nucleoside phosphorylase PyNPase in tumor tissues compared to normal tissues The end result is higher concentrations of 5-fluorouracil in tumor relative to surrounding normal tissue This trial will investigate the activity of this novel capecitabineoxaliplatin CAPOX combination in patients with advanced disease In addition an exploratory analysis will correlate response with thymidine synthase and thymidine phosphorylase expression in primary tumor samples
Detailed Description:
OUTLINE This is a multi-center study
CAPOX 21 day cycle
Capecitabine 825 mgm2 orally twice daily Days 1-14
Oxaliplatin 100 mgm2 intravenously Day 1
Patients may continue combination therapy until progression or toxicity intervenes Patients who discontinue either agent due to toxicity may at the investigators discretion continue therapy with the remaining single agent on study
ECOG performance status 0 or 1
Hematopoietic
ANC 1200mm3
Platelets 100000mm3
Hepatic
Total bilirubin 15 x ULN
AST 2 x ULN up to 5 x ULN in patients with known liver involvement
Renal
Serum creatinine 15 x ULN and estimated creatinine clearance 50mlmin as calculated with Cockroft-Gault equation
Cardiovascular
No clinically significant cardiac disease eg congestive heart failure symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or myocardial infarction within the last 12 months
CAPOX 21 day cycle
Capecitabine 825 mgm2 orally twice daily Days 1-14
Oxaliplatin 100 mgm2 intravenously Day 1
Patients may continue combination therapy until progression or toxicity intervenes Patients who discontinue either agent due to toxicity may at the investigators discretion continue therapy with the remaining single agent on study
ECOG performance status 0 or 1
Hematopoietic
ANC 1200mm3
Platelets 100000mm3
Hepatic
Total bilirubin 15 x ULN
AST 2 x ULN up to 5 x ULN in patients with known liver involvement
Renal
Serum creatinine 15 x ULN and estimated creatinine clearance 50mlmin as calculated with Cockroft-Gault equation
Cardiovascular
No clinically significant cardiac disease eg congestive heart failure symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or myocardial infarction within the last 12 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