Status:
COMPLETED
UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer
Lead Sponsor:
University of Michigan Rogel Cancer Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
HER-2 Positive Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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. Howeve...
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. Howeve...
Eligibility Criteria
Inclusion
- Patients with biopsy proven, measurable metastatic breast cancer. Patients with bone-only, and/or effusion-only disease are excluded.
- HER-2 neu positive by standard immunohistochemical criteria (2+ positivity).
- No prior chemotherapy for distant metastatic disease.
- Prior paclitaxel in the adjuvant setting is allowed.
- Karnofsky performance status equal to 70 or greater.
- ANC \> 1500, Hgb \> 10, plt \> 100.
- 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
- 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).
Key Trial Info
Start Date :
March 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00146042
Start Date
March 1 1999
End Date
March 1 2005
Last Update
October 5 2012
Active Locations (1)
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1
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109