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
OUTLINE: This is a multi-center study.
- CAPOX-T (21 day cycle):Capecitabine 825 mg/m2 orally twice daily Days 1-14Oxaliplatin
100 mg/m2 intravenously Day 1
- Trastuzumab : 6 mg/kg intravenously Day 1.8mg/kg 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 > 1,200/mm3·
- Platelets > 100,000/mm3
Hepatic:·
- Total bilirubin < 1.5 x ULN·
- AST < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
Renal:·
- Serum creatinine < 1.5 x ULN and estimated creatinine clearance >50ml/min as calculated
with Cockroft-Gault equation
Cardiovascular:·
- No clinically significant cardiac disease (e.g. 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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- · To determine the objective response rate (CR+PR) of capecitabine, oxaliplatin and trastuzumab(CAPOX-T) in patients with HER2 positive metastatic breast cancer.
18 months
No
Kathy Miller, M.D.
Study Chair
Hoosier Oncology Group, LLC
United States: Institutional Review Board
HOG BRE03-61
NCT00216073
March 2004
October 2006
Name | Location |
---|---|
Indiana University Cancer Center | Indianapolis, Indiana 46202-5265 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
Medical & Surgical Specialists, LLC | Galesburg, Illinois 61401 |
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Elkhart Clinic | Elkhart, Indiana 46515 |
Community Regional Cancer Center | Indianapolis, Indiana 46256 |
Quality Cancer Center (MCGOP) | Indianapolis, Indiana 46202 |
Medical Consultants, P.C. | Muncie, Indiana 47303 |
AP&S Clinic | Terre Haute, Indiana 47804 |
Fort Wayne Oncology & Hematology, Inc | Fort Wayne, Indiana 46815 |
Center for Hematology/Oncology of S. Michigan | Jackson, Michigan 49201 |