Overview
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
Status:
Completed
Completed
Trial end date:
2003-07-01
2003-07-01
Target enrollment:
0
0
Participant gender:
Female
Female
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Vanderbilt-Ingram Cancer CenterCollaborator:
National Cancer Institute (NCI)Treatments:
Docetaxel
Trastuzumab
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed recurrent or metastatic breast cancerHER2-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