NCT00537173

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Hoosier Cancer Research Network · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Core Biopsy	biopsy
PROCEDURE	Blood Collection	Blood/serum sample
DRUG	Paclitaxel	Paclitaxel 90 mg/m2 IV, day 1, 8 and 15
DRUG	Avastin	Avastin 10 mg/kg IV, day 1 and 15

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2007-09-28
• Last updated: 2017-01-25

Locations

4 sites across 1 country: United States