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NCT00216073 · ClinicalTrials.gov registry record · Phase 2
Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by Hoosier Cancer Research Network.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00216073 is a Phase 2 study that was terminated before completion, run by Hoosier Cancer Research Network. The registered enrollment target is 11 participants.
The verdict
NCT00216073, a Phase 2 study, was terminated before completion, sponsored by Hoosier Cancer Research Network.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
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.
Interventions
- DRUG Trastuzumab
- DRUG Capecitabine
- DRUG Oxaliplatin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2004-03 |
| Est. Completion | 2006-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00216073
The ClinicalTrials.gov registry entry for NCT00216073 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 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 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT00216073 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00216073 about?
NCT00216073 is a clinical study titled "Capecitabine, Oxaliplatin and Trastuzumab in Treating Patients With HER2 Positive 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 NCT00216073?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2004-03. Estimated completion is 2006-10.
What interventions are being tested in trial NCT00216073?
The interventions under investigation include: Trastuzumab (DRUG), Capecitabine (DRUG), Oxaliplatin (DRUG).
Who is sponsoring clinical trial NCT00216073?
This trial is sponsored by Hoosier Cancer Research Network, which has 26 total clinical trials registered on ClinicalTrials.gov.
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