UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer
Status:
Completed
Trial end date:
2005-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Michigan Cancer Center University of Michigan Rogel Cancer Center