Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study
OUTLINE: This is a multi-center study.
Sample Collection:
- Core biopsy
- Blood sample
28-day Cycle Treatment Regimen:
- Paclitaxel 90 mg/m2 IV D1, 8, and 15
- Avastin 10 mg/kg IV D1 and 15
ECOG Performance Status of 0 or 1
Life Expectancy: Not specified
Hematopoietic:
- Platelet count > 100,000/mm³
- Absolute neutrophil count > 1200/mm³
- PTT < 1.5 x upper limit of normal
- INR < 1.5 x upper limit of normal
Hepatic:
- Total bilirubin < 1.5 mg/dL
- SGOT (AST) < 2 x upper limit of normal
Renal: Not specified
Cardiovascular:
- Clinically significant cardiovascular or cerebrovascular disease including prior
myocardial infarction (within 6 months prior to study entry), unstable angina, Grade II
or greater peripheral vascular disease, New York Heart Association (NYHA) Grade II or
greater congestive heart failure, hypertensive crises, hypertensive encephalopathy or
uncontrolled hypertension (SBP>150, DBP>100).
Observational
Time Perspective: Prospective
To correlate tumor gene expression (genomic profile) with response to paclitaxel + Avastin in patients with advanced breast cancer
36 months
No
George Sledge, M.D.
Principal Investigator
Hoosier Oncology Group, Inc.
United States: Institutional Review Board
HOG COE-02
NCT00537173
September 2007
August 2009
Name | Location |
---|---|
Cancer Care Center Of Southern Indiana | Bloomington, Indiana 47403 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
Baylor College of Medicine - Methodist Breast Center | Houston, Texas 77030 |
Indiana University Simon Cancer Center | Indianapolis, Indiana 46202 |