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Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer
NCT00216021 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Capecitabine
- DRUG Oxaliplatin
Study Locations (11)
Indiana
- Elkhart Clinic — Elkhart
- Oncology Hematology Associates of SW Indiana — Evansville
- Indiana University Cancer Center — Indianapolis
- Quality Cancer Center (MCGOP) — Indianapolis
- Community Regional Cancer Center — Indianapolis
- Medical Consultants, P.C. — Muncie
- Center for Cancer Care, Inc., P.C. — New Albany
- Northern Indiana Cancer Research Consortium — South Bend
- AP&S Clinic — Terre Haute
Delaware
- Helen F. Graham Cancer Center — Newark
Illinois
- Medical & Surgical Specialists, LLC — Galesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2004-03 |
| Est. Completion | 2007-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216021
The ClinicalTrials.gov registry entry for NCT00216021 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoosier Cancer Research Network, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00216021 reports 11 study locations spanning 3 distinct geographic areas — top geographies include Indiana, Delaware, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00216021 about?
NCT00216021 is a clinical study titled "Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer". 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 fluoropyrimidi...
What is the current status of trial NCT00216021?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2004-03. Estimated completion is 2007-06.
What conditions does trial NCT00216021 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00216021?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00216021?
This trial is sponsored by Hoosier Cancer Research Network, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00216021 being conducted?
This trial has 11 study locations across Delaware, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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