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

PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 31, 1999

Primary Completion Date

September 30, 2004

Study Completion Date

February 28, 2006

Conditions
Metastatic Breast Cancer
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.

Trial Locations (1)

48109

University of Michigan Cancer Center, Ann Arbor

All Listed Sponsors
collaborator

Aventis Pharmaceuticals

INDUSTRY

collaborator

Rhone-Poulenc Rorer

INDUSTRY

lead

University of Michigan Rogel Cancer Center

OTHER