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NCT00216021 · ClinicalTrials.gov registry record · Phase 2
Capecitabine and Oxaliplatin in Treating Patients With Metastatic Breast Cancer
A Phase 2 study of Metastatic Breast Cancer, sponsored by Hoosier Cancer Research Network.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 11
- Study locations
NCT00216021 is a Phase 2 study of Metastatic Breast Cancer that has completed, run by Hoosier Cancer Research Network. The registered enrollment target is 25 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (88% lower). The trial reports 11 study locations across 3 states.
The verdict
NCT00216021, a Phase 2 study of Metastatic Breast Cancer, has completed, sponsored by Hoosier Cancer Research Network.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 11
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (88% lower). The listed sponsor is Hoosier Cancer Research Network, which has 26 total studies on file at ClinicalTrials.gov.
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.
NCT00216021 reports 11 study locations spanning 3 distinct geographic areas - top geographies include Indiana, Delaware, Illinois.
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.
What interventions are being tested in trial NCT00216021?
The interventions under investigation include: Capecitabine (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00216021?
This trial is sponsored by Hoosier Cancer Research Network, which has 26 total clinical trials registered on ClinicalTrials.gov.
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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Read our methodology - how this data is sourced, computed, and verified.
Related
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