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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer

Thank you

Trial Information

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


Inclusion Criteria:



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

- HER2 gene amplification by FISH. HER protein overexpression by immunohistochemistry
will not be sufficient for entry.·

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

- Prior hormonal therapy for metastatic disease is allowed.

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

- 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.·

- 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 current 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, oxaliplatin and trastuzumab(CAPOX-T) in patients with HER2 positive metastatic breast cancer.

Outcome Time Frame:

18 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 BRE03-61

NCT ID:

NCT00216073

Start Date:

March 2004

Completion Date:

October 2006

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

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