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Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer

NCT00216073 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2011-05-02

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. Trastuzumab is synergistic in vitro with multiple chemotherapeutic agents including the platinum compounds. Studies have shown the efficacy of trastuzumab combined with chemotherapy in patients with HER2 overexpressing metastatic breast cancer. This trial will investigate the activity of capecitabine and oxaliplatin administered with trastuzumab (CAPOX-T) in patients with HER2 overexpressing in patients with advanced disease.

Conditions

Interventions

DRUG

Capecitabine

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

DRUG

Oxaliplatin

Oxaliplatin 100 mg/m2 IV, day 1

DRUG

Trastuzumab

Trastuzumab 6mg/kg IV, day 1. 8 mg/kg loading dose given in cycle 1 for patients without previous trastuzumab therapy only.

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
NON_RANDOMIZED
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
2006-10-31
Completion
2006-10-31

Countries

  • United States

Study Locations

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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 NCT00216073 on ClinicalTrials.gov