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Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer

Sponsor
Vanderbilt-Ingram Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00006104
Collaborator
National Cancer Institute (NCI) (NIH)
46
Enrollment
15
Locations
58
Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES: I. Determine the objective response rate of women with HER2-neu overexpressing recurrent or metastatic breast cancer treated with trastuzumab (Herceptin) in combination with docetaxel. II. Determine the toxicity of this treatment regimen in these patients. III. Determine the duration of response to this treatment regimen in these patients. IV. Determine the time to progression in these patients after receiving this treatment regimen. V. Compare HER2-neu overexpression as determined by fluorescent in situ hybridization (FISH) versus immunohistochemistry, and correlate these findings with response to this treatment regimen in these patients. VI. Correlate HER2-neu activation by immunohistochemistry and the extracellular domain of HER2-neu by ELISA with response to this treatment regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30 minutes weekly for 6 weeks plus trastuzumab (Herceptin) IV over 30-90 minutes weekly for 8 weeks. Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months, every 3 months for 9 months, and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 18-34 patients will be accrued for this study.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Primary Purpose:
Treatment
Official Title:
A Multi-Institutional Phase II Pilot Trial With Weekly Docetaxel and Herceptin as First or Second Line Therapy for HER2/Neu Overexpressing Metastatic Breast Cancer
Study Start Date :
Sep 1, 1998
Actual Primary Completion Date :
Jul 1, 2003
Actual Study Completion Date :
Jul 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancer HER2-neu overexpressing tumor (2+ or 3+) Measurable or evaluable disease If bone disease only, must have lytic lesions No carcinomatous meningitis or untreated or uncontrolled brain parenchymal disease Prior brain parenchymal disease allowed if controlled by appropriate therapy given at least 8 weeks prior to study, and patient is asymptomatic from CNS disease Hormone receptor status: Not specified

    PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN) SGOT and SGPT no greater than 1.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No congestive heart failure Ejection fraction greater than 45% by MUGA No myocardial infarction within the past 6 months No ischemic heart disease requiring medication No uncontrolled hypertension Other: No peripheral neuropathy grade 2 or more No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral breast cancer No active unresolved infection No history of hypersensitivity reaction to products containing Polysorbate 80 No poorly controlled diabetes mellitus Not pregnant Negative pregnancy test Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifiers Chemotherapy: Prior adjuvant chemotherapy allowed No more than 1 prior chemotherapy regimen for metastatic disease No prior taxane (docetaxel or paclitaxel) Prior doxorubicin allowed if total dose less than 250 mg/m2 No other concurrent chemotherapy Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: At least 4 weeks since prior radiotherapy No prior cumulative radiotherapy to more than 25% of bone marrow No concurrent radiotherapy Surgery: Not specified Other: At least 7 days since prior antibiotics No other concurrent investigational drugs No other concurrent antineoplastic therapy No concurrent parenteral antibiotics

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Hospital Mobile Alabama United States 36608
    2 Robert H. Lurie Comprehensive Cancer Center, Northwestern University Chicago Illinois United States 60611-3013
    3 Evanston Hospital Evanston Illinois United States 60201
    4 Owensboro Medical Health System Owensboro Kentucky United States 42303
    5 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    6 Erlanger Health Systems Chattanooga Tennessee United States 37403
    7 Memorial Health Care System Chattanooga Tennessee United States 37404
    8 Williamson Medical Center Franklin Tennessee United States 37067
    9 Jackson-Madison County Hospital Jackson Tennessee United States 38301
    10 Methodist/Thompson Oncology Research Knoxville Tennessee United States 37916
    11 Tennessee Cancer Specialists Knoxville Tennessee United States 37920
    12 Boston Baskin Cancer Group Memphis Tennessee United States 38104
    13 St. Thomas Health Services Nashville Tennessee United States 37205
    14 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-6838
    15 Methodist Medical Center of Oak Ridge Oak Ridge Tennessee United States 37831

    Sponsors and Collaborators

    • Vanderbilt-Ingram Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Ingrid Mayer, MD, Vanderbilt-Ingram Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ingrid Mayer, MD, Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
    ClinicalTrials.gov Identifier:
    NCT00006104
    Other Study ID Numbers:
    • VICC BRE 9823
    • P30CA068485
    • VU-VCC-BRE-9823
    • NCI-G00-1830
    First Posted:
    Dec 24, 2003
    Last Update Posted:
    Aug 14, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Ingrid Mayer, MD, Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center
    stage IV breast cancer
    recurrent breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Docetaxel
    Trastuzumab

    Study Results

    No Results Posted as of Aug 14, 2012