Status:
COMPLETED
AZD2171 and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
RATIONALE: AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, c...
Detailed Description
OBJECTIVES: Primary * Determine the overall pathologic complete response rate in women with previously untreated, locally advanced breast cancer treated with neoadjuvant AZD2171, doxorubicin hydroch...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast cancer, meeting 1 of the following criteria:
- Previously untreated disease
- Inflammatory disease
- Locally advanced breast cancer (stage IIIA, IIIB, or IIIC disease)
- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion (longest diameter) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan or breast MRI
- Accessible tumor tissue for serial biopsy
- No overexpression of HER2
- No known brain metastases secondary to breast cancer
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Karnofsky performance status 60-100%
- Life expectancy \> 3 months
- Female only
- Menopausal status not specified
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Hemoglobin ≥ 8 g/dL
- Bilirubin normal (≤ 2 times upper limit of normal \[ULN\] if evidence of Gilbert's disease and elevated bilirubin not related to tumor or other liver disease)
- AST and ALT ≤ 2.5 ULN
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Proteinurea ≤ +1 on 2 consecutive dipsticks at least 1 week apart
- INR ≤ 1.5
- LVEF ≥ 50% by MUGA or echocardiogram without clinical symptoms or signs of heart failure
- Fertile patients must use effective contraception
- Not pregnant or nursing
- Negative pregnancy test
- No peripheral neuropathy ≥ grade 2
- No known CNS disease, including history of stroke or seizures not controlled by standard medical therapy
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel, doxorubicin hydrochloride, or cyclophosphamide
- No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Hypertension
- Ongoing or active infection requiring IV antibiotics
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Peripheral vascular disease ≥ grade II
- Psychiatric illness/social situation that would preclude study treatment
- No nonhealing wounds or bone fractures within the past 28 days
- No history of an active malignancy except carcinoma in situ of the cervix or nonmelanomatous skin cancer in the past 5 years
- PRIOR CONCURRENT THERAPY:
- No prior surgery, chemotherapy, or hormonal therapy for breast cancer
- No concurrent medication that may affect renal function (e.g., amphotericin B or pentamidine)
- No full-dose oral or parenteral anticoagulants or chronic daily treatment with aspirin (dose \> 325 mg/day) within the past 10 days
- No other concurrent investigational agents
- No other concurrent commercially available drugs for this cancer
- No concurrent antiretroviral therapy for known HIV infection
- No major surgery within the past 28 days
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00310089
Start Date
January 1 2006
End Date
July 1 2007
Last Update
June 20 2013
Active Locations (2)
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1
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
2
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903