Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2004
End Date:June 2007

Use our guide to learn which trials are right for you!

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

In vitro data suggest synergy between oxaliplatin and 5-FU. The combination of oxaliplatin
with 5-fluorouracil produced objective response rates ranging from 27-34% in two studies of
patients with prior chemotherapy. Capecitabine was designed as an orally administered, tumor
selective fluoropyrimidine, preferentially converted to 5-FU at the tumor site by the higher
levels of pyrimidine nucleoside phosphorylase (PyNPase) in tumor tissues compared to normal
tissues. The end result is higher concentrations of 5-fluorouracil in tumor relative to
surrounding normal tissue. This trial will investigate the activity of this novel
capecitabine/oxaliplatin (CAPOX) combination in patients with advanced disease. In addition,
an exploratory analysis will correlate response with thymidine synthase and thymidine
phosphorylase expression in primary tumor samples.

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.
We found this trial at
11
sites
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
303 S Nappanee St
Elkhart, Indiana 46514
(574) 296-3200
Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
?
mi
from
Elkhart, IN
Click here to add this to my saved trials
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Galesburg, Illinois 61401
?
mi
from
Galesburg, IL
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Muncie, Indiana 47303
?
mi
from
Muncie, IN
Click here to add this to my saved trials
New Albany, Indiana 47150
?
mi
from
New Albany, IN
Click here to add this to my saved trials
Newark, Delaware 19713
?
mi
from
Newark, DE
Click here to add this to my saved trials
615 N Michigan Street
South Bend, Indiana 46601
(574) 647-7370
Northern Indiana Cancer Research Consortium The Northern Indiana Cancer Research Consortium (NICRC) is comprised of...
?
mi
from
South Bend, IN
Click here to add this to my saved trials
Terre Haute, Indiana 47804
?
mi
from
Terre Haute, IN
Click here to add this to my saved trials