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A Phase II Trial of Capecitabine and Oxaliplatin (CAPOX) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE03-60

Phase 2
18 Years
Not Enrolling
Metastatic Breast Cancer

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Trial Information

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.

Inclusion Criteria:

- Histologic or cytologic diagnosis of breast cancer with evidence of (1)
unresectable, locally recurrent, or (2) metastatic disease.·

- Patients with HER2 positive (3+ overexpression by IHC or gene amplification by FISH)
are eligible only if they have had prior trastuzumab therapy.·

- At least one measurable lesion as defined by the RECIST.

- Prior radiation therapy is allowed as long as the irradiated area is not the only
source of measurable disease.

Exclusion Criteria:

- No prior therapy with capecitabine or oxaliplatin in any setting

- No prior therapy with other platinum compounds·

- No other forms of cancer therapy including radiation, chemotherapy and hormonal
therapy within 21 days prior to beginning protocol therapy.·

- No prior unanticipated severe reaction to fluoropyrimidine therapy, or known
sensitivity to 5-fluorouracil.·

- No prior fluoropyrimidine therapy for metastatic disease is allowed. Prior adjuvant
fluoropyrimidine therapy is allowed if completed > 12 months from study entry.·

- Maximum of one prior chemotherapy regimen for unresectable, locally recurrent or
metastatic disease·

- No symptomatic brain metastasis. ·

- No evidence of serious concomitant systemic disorders incompatible with the study ·

- No peripheral neuropathy ·

- No major surgery within 28 days prior to beginning protocol therapy.·

- Negative pregnancy test·

- No female patients currently breastfeeding·

- No malabsorption syndrome·

- No evidence of serious concomitant systemic disorders incompatible with the study·

- Patients must not be treated with any of the following while on protocol therapy or
within 28 days prior to beginning protocol therapy: sorivudine, brivudine,
cimetidine, allopurinol.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

- To determine the objective response rate (CR+PR) of capecitabine and oxaliplatin (CAPOX) in patients with metastatic breast cancer.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Kathy Miller, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Hoosier Oncology Group, LLC


United States: Institutional Review Board

Study ID:

HOG BRE03-60



Start Date:

March 2004

Completion Date:

June 2007

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
Helen F. Graham Cancer CenterNewark, Delaware  19713
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
Oncology Hematology Associates of SW IndianaEvansville, Indiana  47714
Elkhart ClinicElkhart, Indiana  46515
Community Regional Cancer CenterIndianapolis, 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 ClinicTerre Haute, Indiana  47804