A Phase II Trial of Capecitabine and Oxaliplatin (CAPOX) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE03-60
18 Years
N/A
Female
Metastatic Breast Cancer
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
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.
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:
Interventional
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:
No
Principal Investigator
Kathy Miller, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Hoosier Oncology Group, LLC
Authority:
United States: Institutional Review Board
Study ID:
HOG BRE03-60
NCT ID:
NCT00216021
Start Date:
March 2004
Completion Date:
June 2007
Related Keywords:
- Metastatic Breast Cancer
- Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| 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 |
