UMCC 9901: Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive Metastatic Breast Cancer - Full Text View

Sponsor:	University of Michigan Cancer Center
Collaborator:	Genentech
Information provided by:	University of Michigan Cancer Center
ClinicalTrials.gov Identifier:	NCT00146042

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. The drug, docetaxel, is combined with another drug, trastuzumab (Herceptin), because at this time this combination appears to be promising in metastatic breast cancer research.

Condition	Intervention	Phase
HER-2 Positive Metastatic Breast Cancer	Drug: Docetaxel Drug: Trastuzumab Procedure: Erythromycin Breath Test (ERMBT)	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Tailored-Dose Docetaxel + Trastuzumab in Her-2 Positive 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 Erythromycin stearate Erythromycin ethylsuccinate Docetaxel Trastuzumab

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: 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

• To evaluate the safety and efficacy of tailored-dose docetaxel + trastuzumab in HER-2 neu positive women as first-line treatment in metastatic breast cancer. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
• To evaluate the efficacy of tailored-dose docetaxel + trastuzumab in HER-2 neu positive women, in terms of response rate and time to progression. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
• To explore the relationship between response to therapy and HER-2 status by differential polymerase chain reaction (PCR) vs. protein immunohistochemistry. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	22
Study Start Date:	March 1999
Study Completion Date:	March 2005
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

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.
HER-2 neu positive by standard immunohistochemical criteria (2+ positivity).
No prior chemotherapy for distant metastatic disease.
Prior paclitaxel in the adjuvant setting is allowed.
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: NCT00146042

Locations

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

Sponsors and Collaborators

University of Michigan Cancer Center

Genentech

Investigators

Principal Investigator:

Anne Schott, MD

University of Michigan Cancer Center

More Information

No publications provided

Responsible Party:	The Cancer Answer Line, U of M
ClinicalTrials.gov Identifier:	NCT00146042 History of Changes
Other Study ID Numbers:	UMCC 9901, H1880n
Study First Received:	September 1, 2005
Last Updated:	February 5, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Erythromycin stearate
Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Docetaxel

Trastuzumab
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 May 24, 2012