Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
NCT ID: NCT00006104
Last Updated: 2012-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
1998-09-30
2003-07-31
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic breast cancer.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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trastuzumab
docetaxel
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Ingrid Mayer, MD
Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist
Principal Investigators
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Ingrid Mayer, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Providence Hospital
Mobile, Alabama, United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, United States
Evanston Hospital
Evanston, Illinois, United States
Owensboro Medical Health System
Owensboro, Kentucky, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Erlanger Health Systems
Chattanooga, Tennessee, United States
Memorial Health Care System
Chattanooga, Tennessee, United States
Williamson Medical Center
Franklin, Tennessee, United States
Jackson-Madison County Hospital
Jackson, Tennessee, United States
Methodist/Thompson Oncology Research
Knoxville, Tennessee, United States
Tennessee Cancer Specialists
Knoxville, Tennessee, United States
Boston Baskin Cancer Group
Memphis, Tennessee, United States
St. Thomas Health Services
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Methodist Medical Center of Oak Ridge
Oak Ridge, Tennessee, United States
Countries
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Other Identifiers
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VU-VCC-BRE-9823
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1830
Identifier Type: -
Identifier Source: secondary_id
VICC BRE 9823
Identifier Type: -
Identifier Source: org_study_id