Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- To assess whether assignment of docetaxel dose based on the ERMBT will result in decreased variability in drug area under the curve when compared to dosing based on body surface area.
Study Overview
Brief 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.
Detailed Description
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. Patients participating in this study will have biopsy proven, measurable metastatic breast cancer.
During the study:
-Patients will receive tailored-dose docetaxel for their breast cancer.
Approximately 45 subjects will be recruited at this site.
Diagnosis and Staging
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with biopsy proven, measurable metastatic breast cancer. Patients with bone-only, and/or effusion-only disease are excluded.
- •Karnofsky performance status equal to 70 or greater.
- •ANC > 1500, Hgb > 10, plt >
- •Patients with some degree of hepatic dysfunction and renal dysfunction are encouraged, in order to evaluate the ability of the ERMBT in tailoring dose in these patient populations.
Exclusion Criteria
- •Age less than 18 years.
- •Allergy to erythromycin.
- •Previous treatment with docetaxel. Prior paclitaxel is allowed.
- •Grade > 2 peripheral neuropathy.
- •No confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy).
- •Patients who are pregnant or nursing will not be eligible for this protocol. Women of childbearing age who are not practicing reliable birth control must have a documented negative serum HCG.
- •Patients who require concurrent treatment with drugs which are known to induce or inhibit CYP3A activity will be ineligible for the trial. This list includes the drugs midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, anti-seizure drugs, and rifampin (induction).
Outcomes
Primary Outcomes
To assess whether assignment of docetaxel dose based on the ERMBT will result in decreased variability in drug area under the curve when compared to dosing based on body surface area.
Time Frame: 12 months
Secondary Outcomes
- To evaluate the safety and efficacy of tailored-dose docetaxel in metastatic breast cancer.(12 months)