Breast Cancer Clinical Trial
Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Summary
This phase II trial is to see if combining bevacizumab with docetaxel works in treating women who have locally advanced or metastatic breast cancer. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.
Full Description
PRIMARY OBJECTIVES:
I. Determine the response rate in women with locally advanced or metastatic breast cancer treated with bevacizumab and docetaxel.
II. Determine the side effects of this regimen in these patients. III. Correlate soluble activated endothelial cell markers and adhesion molecules, quantitation of tumor and/or endothelial cell apoptosis, and quantitation of microvessel density with clinical outcome in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on weeks 1 and 3 and docetaxel IV over 60 minutes on weeks 1, 2, and 3. Treatment repeats every 4 weeks for up to 12 courses in the absence of unacceptable toxicity or disease progression. After completion of 6 courses of combined treatment, patients with an ongoing response may receive bevacizumab alone in the absence of disease progression.
PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 14-27 months.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed breast cancer
Local-regional recurrences or metastatic disease
At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases)
Hormone receptor status:
Not specified
Female
Performance status - ECOG 0-2
Performance status - Karnofsky 60-100%
More than 3 months
WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
No bleeding diathesis or coagulopathy
Bilirubin normal
AST/ALT no greater than 2.5 times upper limit of normal
INR less than 1.5 (patients receiving warfarin)
Creatinine normal
Creatinine clearance at least 60 mL/min
No baseline proteinuria
Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg
No symptomatic congestive heart failure
No cardiac arrhythmia
No uncontrolled hypertension
No history of stroke
No clinically significant peripheral artery disease
No arterial thromboembolic event within the past 6 months, including any of the following:
Transient ischemic attack
Cerebrovascular accident
Unstable angina
Myocardial infarction
HIV negative
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No seizures not controlled with standard medical therapy
No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents
No psychiatric illness or social situation that would preclude study compliance
No ongoing or active infection
No other concurrent uncontrolled illness
No non-healing wounds
No significant traumatic injury within the past 28 days
Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease)
More than 6 months since prior taxane-containing adjuvant chemotherapy
More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
More than 3 weeks since prior radiotherapy
More than 28 days since prior major surgery or open biopsy
More than 7 days since prior fine needle aspirations other than in the breast
More than 7 days since prior placement of a vascular access device
No concurrent major surgical procedure
No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters)
No other concurrent investigational agents
No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications (known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 2 Locations for this study
Aurora Colorado, 80045, United States
Columbus Ohio, 43210, United States
How clear is this clinincal trial information?