Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216073
Status:
TERMINATED
Last Update Posted:
2011-05-02
First Post:
2005-09-09
Brief Title:
Capecitabine Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Capecitabine Oxaliplatin and Trastuzumab CAPOX-T in Patients With HER-2 Positive Metastatic Breast Cancer Hoosier Oncology Group BRE03-61
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of patient accrual
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 Trastuzumab is synergistic in vitro with multiple chemotherapeutic agents including the platinum compounds Studies have shown the efficacy of trastuzumab combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer This trial will investigate the activity of capecitabine and oxaliplatin administered with trastuzumab CAPOX-T in patients with HER2 overexpressing in patients with advanced disease
Detailed Description:
OUTLINE This is a multi-center study
CAPOX-T 21 day cycleCapecitabine 825 mgm2 orally twice daily Days 1-14Oxaliplatin 100 mgm2 intravenously Day 1
Trastuzumab 6 mgkg intravenously Day 18mgkg loading dose should be given in cycle 1 for patients without previous trastuzumab therapy only
Patients may continue combination therapy until progression or toxicity intervenes Patients who discontinue either or both cytotoxic agents due to toxicity may at the investigators discretion continue therapy with the remaining agents on study until progressive disease
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
LVEF LLN by MUGA or ECHO
CAPOX-T 21 day cycleCapecitabine 825 mgm2 orally twice daily Days 1-14Oxaliplatin 100 mgm2 intravenously Day 1
Trastuzumab 6 mgkg intravenously Day 18mgkg loading dose should be given in cycle 1 for patients without previous trastuzumab therapy only
Patients may continue combination therapy until progression or toxicity intervenes Patients who discontinue either or both cytotoxic agents due to toxicity may at the investigators discretion continue therapy with the remaining agents on study until progressive disease
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
LVEF LLN by MUGA or ECHO
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