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

Sponsor:	University of Michigan Cancer Center
Collaborators:	Aventis Pharmaceuticals Rhone-Poulenc Rorer
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00148070

Purpose

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.

Condition	Intervention	Phase
Metastatic Breast Cancer	Drug: Docetaxel Procedure: Erythromycin Breath Test (ERMBT)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Erythromycin Gluceptate Erythromycin Docetaxel Erythromycin stearate Erythromycin ethylsuccinate Erythromycin estolate

U.S. FDA Resources

Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:

To assess whether assignment of docetaxel dose based on the ERMBT will result in decreased variability in drug area under the curve when compared to dosing based on body surface area. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and efficacy of tailored-dose docetaxel in metastatic breast cancer. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	45
Study Start Date:	March 1999
Estimated Study Completion Date:	January 2012
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with biopsy proven, measurable metastatic breast cancer. Patients with bone-only, and/or effusion-only disease are excluded.
Karnofsky performance status equal to 70 or greater.
ANC > 1500, Hgb > 10, plt > 100.
Patients with some degree of hepatic dysfunction and renal dysfunction are encouraged, in order to evaluate the ability of the ERMBT in tailoring dose in these patient populations.

Exclusion Criteria:

Age less than 18 years.
Allergy to erythromycin.
Previous treatment with docetaxel. Prior paclitaxel is allowed.
Grade > 2 peripheral neuropathy.
No confounding factors present to provide misinterpretation of data (i.e., concurrent malignancy).
Patients who are pregnant or nursing will not be eligible for this protocol. Women of childbearing age who are not practicing reliable birth control must have a documented negative serum HCG.
Patients who require concurrent treatment with drugs which are known to induce or inhibit CYP3A activity will be ineligible for the trial. This list includes the drugs midazolam, anti-mycotic agents (ketoconazole and related compounds), macrolide antibiotics (erythromycin and related compounds), nifedipine, anti-seizure drugs, and rifampin (induction).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00148070

Locations

United States, Michigan
University of Michigan Cancer Center
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan Cancer Center

Aventis Pharmaceuticals

Rhone-Poulenc Rorer

Investigators

Principal Investigator:

Anne Schott, MD

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	University of Michigan Comprehensive Cancer Center ( Dr. Anne Schott )
Study ID Numbers:	UMCC 9900, GIA#11119, IRBMED 1999-121
Study First Received:	September 2, 2005
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00148070 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Erythromycin stearate
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Erythromycin Ethylsuccinate
Gastrointestinal Agents
Breast Neoplasms
Enzyme Inhibitors
Erythromycin

Pharmacologic Actions
Docetaxel
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Neoplasms
Neoplasms by Site
Erythromycin Estolate
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010