A Phase II Trial of Capecitabine and Oxaliplatin (CAPOX) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE03-60
OUTLINE: This is a multi-center study.
CAPOX (21 day cycle):
- Capecitabine 825 mg/m2 orally twice daily Days 1-14.
- Oxaliplatin 100 mg/m2 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
- ANC > 1,200/mm3·
- Platelets > 100,000/mm3
- Total bilirubin < 1.5 x ULN·
- AST < 2 x ULN (up to 5 x ULN in patients with known liver involvement)
- Serum creatinine < 1.5 x ULN and estimated creatinine clearance >50ml/min as calculated
with Cockroft-Gault equation
- 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.
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 and oxaliplatin (CAPOX) in patients with metastatic breast cancer.
Kathy Miller, M.D.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Helen F. Graham Cancer Center||Newark, Delaware 19713|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Oncology Hematology Associates of SW Indiana||Evansville, Indiana 47714|
|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|
|Center for Cancer Care, Inc., P.C.||New Albany, Indiana 47150|
|AP&S Clinic||Terre Haute, Indiana 47804|