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

This study has been completed.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Rhone-Poulenc Rorer
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT00148070
First received: September 2, 2005
Last updated: October 3, 2012
Last verified: October 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Tailored-Dose Docetaxel in Metastatic Breast Cancer

Resource links provided by NLM:


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
Study Completion Date: February 2006
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Cancer Center
ClinicalTrials.gov Identifier: NCT00148070     History of Changes
Other Study ID Numbers: UMCC 9900, GIA#11119, IRBMED 1999-121
Study First Received: September 2, 2005
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Docetaxel
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014