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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: Completed Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.
NCT00146042 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00146042 record still lists
NCT00146042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT00146042 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00146042's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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