Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer
Public ClinicalTrials.gov record NCT00216021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II Trial of Capecitabine and Oxaliplatin (CAPOX) in Patients With Metastatic Breast Cancer: Hoosier Oncology Group BRE03-60
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00216021
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 25 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2004
- Primary completion
- May 31, 2007
- Completion
- May 31, 2007
- Last update posted
- Dec 8, 2015
2004 – 2007
United States locations
- U.S. sites
- 11
- U.S. states
- 3
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Helen F. Graham Cancer Center | Newark | Delaware | 19713 | — |
| Medical & Surgical Specialists, LLC | Galesburg | Illinois | 61401 | — |
| Elkhart Clinic | Elkhart | Indiana | 46515 | — |
| Oncology Hematology Associates of SW Indiana | Evansville | Indiana | 47714 | — |
| Indiana University Cancer Center | Indianapolis | Indiana | 46202 | — |
| Quality Cancer Center (MCGOP) | Indianapolis | Indiana | 46202 | — |
| Community Regional Cancer Center | Indianapolis | Indiana | 46256 | — |
| Medical Consultants, P.C. | Muncie | Indiana | 47303 | — |
| Center for Cancer Care, Inc., P.C. | New Albany | Indiana | 47150 | — |
| Northern Indiana Cancer Research Consortium | South Bend | Indiana | 46601 | — |
| AP&S Clinic | Terre Haute | Indiana | 47804 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00216021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2015 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00216021 live on ClinicalTrials.gov.