NCT00310089已完成不适用
A Pilot Study to Evaluate The Effects of Neoadjuvant AZD2171, a VEGF Receptor Tyrosine Kinase Inhibitor With Docetaxel, Doxorubicin, and Cyclophosphamide Chemotherapy in Previously Untreated Locally Advanced Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
研究概览
简要总结
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, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD2171 together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed and may kill more tumor cells.
PURPOSE: This randomized clinical trial is studying how well giving AZD2171 together with combination chemotherapy works in treating women with locally advanced breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine the overall pathologic complete response rate in women with previously untreated, locally advanced breast cancer treated with neoadjuvant AZD2171, doxorubicin hydrochloride, cyclophosphamide, and docetaxel.
Secondary
- Compare changes in pretreatment levels of pKDR after 1 course of AZD2171 vs no medication.
- Determine the number of patients who respond to combination therapy beginning with the second course of therapy.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the changes in tumor proliferation (Ki67) in these patients.
- Determine the pharmacokinetics and pharmacogenetics of this regimen in these patients.
- Correlate angiogenic parameters with tumor response in these patients.
- Determine tumor vascularity and permeability before and after treatment as seen on dynamic contrast-enhanced MRI and initial area under the gadolinium curve.
- Determine tumor choline levels before and after treatment as measured by quantitative single-voxel MR spectroscopy and correlate with response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
AZD2171 + Chemotherapy in Advanced NSCLC, Colorectal Cancer, or Other Cancer Suitable for Treatment With Capecitabine (Non-Small Lung Cancer Patients Closed to Enrollment as 8/9/07)Unspecified Adult Solid Tumor, Protocol SpecificColorectal CancerLung CancerNCT00107250NCIC Clinical Trials Group50
已完成
2 期
Cediranib Maleate in Treating Patients With Locally Advanced or Metastatic Liver CancerAdult Primary Hepatocellular CarcinomaAdvanced Adult Primary Liver CancerLocalized Unresectable Adult Primary Liver CancerNCT00238394National Cancer Institute (NCI)44
已完成
2 期
A Phase II Study of AZD2171 in Breast Cancer Stage IV (10006202)Recurrent Breast CancerMale Breast CancerStage IV Breast CancerNCT00244881National Cancer Institute (NCI)26
已完成
1 期
AZD2171 and Standard Combination Chemotherapy in Advanced Non-Small Cell Lung Cancer or Colorectal CancerColorectal CancerLung CancerNCT00343408NCIC Clinical Trials Group31
已完成
2 期
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.Advanced Breast CancerNCT00454805AstraZeneca75