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Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer

NCT00216021 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-12-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Capecitabine

Capecitabine 825 mg/m2 po bid, days 1-14

DRUG

Oxaliplatin

Oxaliplatin 100 mg/m2 IV, day 1

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Walther Cancer Institute

    collaborator OTHER

  • Hoosier Cancer Research Network

    lead OTHER

Principal Investigators

  • Kathy Miller, M.D. · Hoosier Oncology Group, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-03-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00216021 on ClinicalTrials.gov