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

NCT00537173 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2017-01-25

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Indiana University School of Medicine

    collaborator OTHER

  • University of Colorado, Denver

    collaborator OTHER

  • Baylor University

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • Hoosier Cancer Research Network

    lead OTHER

Principal Investigators

  • George Sledge, M.D. · Hoosier Oncology Group, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537173 on ClinicalTrials.gov