Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer

Breast Cancer Clinical Trial

Official title: Predicting Response and Toxicity in Patients Receiving Paclitaxel and Avastin for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study

Status Terminated

Clinical Trial Summary

This trial provides a unique opportunity in that it combines genomic, proteomic and pharmacogenomic assessments in patients receiving chemotherapy for advanced breast cancer. To date no other trials have analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, we expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, we expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.

Clinical Trial Description

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). ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00537173
• Study type: Observational
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: N/A
• Start date: September 2007
• Completion date: August 2009