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Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer

NCT00148070 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-10-05

No results posted yet for this study

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. However, some patients metabolize chemotherapy faster or slower than the average person because of a different level of drug metabolizing enzyme in the liver. Therefore, some patients are either given too small or too large a dose of chemotherapy because the amount of enzyme is not taken into account. This research study will examine the use of a simple test, call the Erythromycin Breath Test(ERMBT) to determine the amount of enzyme which can metabolize the chemotherapy drug docetaxel (Taxotere). The dose of docetaxel will be tailored to the amount of enzyme which is available to metabolize the drug for each patient.

Conditions

Interventions

DRUG

Docetaxel

You will then receive your first dose of docetaxel chemotherapy. It is put through your IV over 1-2 hours. you will receive docetaxel every 3 weeks in the Cancer Center Infusion area.

PROCEDURE

Erythromycin Breath Test (ERMBT)

you will have an erythromycin breath test, which is an experimental test which is used to estimate the amount of enzyme produced by your liver which can metabolize the chemotherapy, docetaxel. For this test, you go to the GCRC where you will receive an injection of erythromycin (an antibiotic) which is labeled with a very small amount of radioactive substance. 20 minutes later you will blow air from your mouth into a blue solution until it clears. Your doctors will calculate the dose of docetaxel to be given to you based on this blood test, on your body's albumin level (a protein determined on the blood test), and on your height and weight.

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Rhone-Poulenc Rorer

    collaborator INDUSTRY

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Anne Schott, MD · University of Michigan Rogel Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-03-31
Primary Completion
2004-09-30
Completion
2006-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00148070 on ClinicalTrials.gov