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NCT00146042 · ClinicalTrials.gov registry record · Phase 2
UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer
A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00146042 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 22 participants.
The verdict
NCT00146042, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient. The drug, docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this combination appears to be promising in metastatic breast cancer research.
Interventions
- DRUG Trastuzumab
- DRUG Docetaxel
- PROCEDURE Erythromycin Breath Test (ERMBT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 1999-03 |
| Est. Completion | 2005-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00146042
The ClinicalTrials.gov registry entry for NCT00146042 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT00146042 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00146042 about?
NCT00146042 is a clinical study titled "UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer". This is a research study which aims to improve the way that doctors determine the dose of chemotherapy given to patients. Right now, chemotherapy is determined by a patient's height and weight. However, some patients metabolize chemotherapy faster or slower than the average person because of a diffe...
What is the current status of trial NCT00146042?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 1999-03. Estimated completion is 2005-03.
What interventions are being tested in trial NCT00146042?
The interventions under investigation include: Trastuzumab (DRUG), Docetaxel (DRUG), Erythromycin Breath Test (ERMBT) (PROCEDURE).
Who is sponsoring clinical trial NCT00146042?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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