NCT01067989终止2 期
Antiangiogenic Treatment Strategy With Metronomic Chemotherapy Regimen Combined With a Cox-2 Inhibitor and a Bisphosphonate for Patients With Metastatic Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)
研究概览
简要总结
Low-dose metronomic(LDM)chemotherapy as well as anti-inflammatory agents and bisphosphonates have shown anti-angiogenic properties on tumor vasculature.
This study is meant to test the therapeutic potential of an anti-angiogenic treatment strategy by combining all these agents for metastatic breast cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic proof of infiltrating duct carcinoma of breast.
- •Her-2 negative tumors.
- •ECOG performance status: 0-
- •Presence of measurable disease: primary and/or metastatic.
- •CBC showing normal values or any toxicity limited to grade I.
- •SMA showing liver and renal functions < 1.5 normal values
- •previous treatment with an anthracycline and with a taxane is mandatory either as neoadjuvant/adjuvant treatment or for metastatic disease.
- •previous treatment by chemotherapy for metastatic disease is allowed (up to three lines, allowing for MTD Capecitabine to be one of them).
- •previous treatment by a bisphosphonate is allowed. However,those patients who up to the study had not received any bisphosphonate and those who had received Clodronate- will receive Pamidronate; those who had been under Pamidronate- will receive Zoledronate; those who had been under Zoledronate- will continue with it."
- •The patient's signature on the informed consent.
排除标准
- •Her-2 neu positive tumor
- •Inability to visit the clinic for outpatient treatment and evaluation
- •Active/symptomatic brain metastases.
- •ECOG performance status: 2-
- •Presence of Hand -Foot syndrome, at grade >
- •CBC with any grade >2 toxicity
- •SMA showing liver functions > 1.5 normal values
- •SMA showing renal functions > normal values -Current continuous treatment by steroids or by NSAIDs, or by anti- coagulants for "non protocol" reasons.
- •presence of exclusively non-measurable disease (I/E: exclusive bone disease with non-representative tumor markers).
- •previous radiotherapy to the "only measurable disease".
- •pleural or peritoneal effusion that may represent a "third space".
- •history of active peptic ulcer.
- •symptomatic coronary heart disease.
研究组 & 干预措施
intervention
Experimental
same treatment for all patients
干预措施: Cyclophosphamide, Capecitabine, Methotrexate, Celecoxib, Pamidronate (or Zoledronate) (Drug)
结局指标
主要结局
To determine the efficacy by rate of clinical benefit (CB): rate of response (RR) + rate of Stable Disease (SD)
时间窗: 6 and 12 months
次要结局
- Plasma Levels of angiogenic growth factors(At 4 predetermined time points along treatment period.)
研究者
LOVEN DAVID
Oncologist
HaEmek Medical Center, Israel
研究点 (1)
Loading locations...
相似试验
进行中（未招募）
不适用
Antiangiogenic Treatment of Advanced or Metastatic Hepatocellular Cancer (HCC) - An open label, stratified, single-arm phase II study of Bevacizumab and RAD001EUCTR2007-005422-76-DEPD Dr. Gerhard Treiber
进行中（未招募）
不适用
Combination of antiangiogenic therapy using the mTOR-inhibitor RAD001 and low dose chemotherapy for locally advanced and/or metastatic pancreatic cancer – a dose finding studyadvanced and/or metastatic pancreatic cancerMedDRA version: 9.1Level: LLTClassification code 10033605Term: Pancreatic cancer metastaticEUCTR2006-003403-39-DEovartis Pharma GmbH
进行中（未招募）
不适用
ow-dose Cytotoxics as Anti-angiogenesis Treatment” following AdjuvantInduction Chemotherapy for Patients with ER-negative and PgR-negativeBreast CancerMaintenance Chemotherapy in Hormone Non- Responsive Breast Cancer - Maintenance Chemotherapy in Hormone Non-Responsive Breast CancerHistologically proven ER-negative and PgRnegative breast cancer with either a total mastectomy with axillary clearance or a lesser procedure with axillary lymph node dissection or sentinel node procedure, and classified as T1a,b,c, T2, T3, or pT4 with minimal dermal invasion, Nx, pN0, pSentN0, pN1, or pN2, and M0. Patients with disease defined as SNB positive are eligible only if they have undergone an axillary dissection, OR are SNB micrometastatic and are randomized to IBCSG Trial 23-01.MedDRA version: 9.1Level: LLTClassification code 10006190Term: Breast cancer invasive NOSEUCTR2005-005666-36-SEInternational Breast Cancer Study Group1,080
Unknown
2 期
Prospective Clinical Trial Evaluating Metronomic Chemotherapy in Patients With High-grade, Operable, Non-metastatic Osteosarcoma of the ExtremityHigh Grade OsteosarcomaNCT02273583Grupo de Apoio ao Adolescente e a Crianca com Cancer738
进行中（未招募）
不适用
Antiangiogenic activity of metronomic therapy with capecitabine in metastatic solid tumors of gastrointestinal tract: a phase II study - Metronomic capecitabineMetastatic solid tumors of gastrointestinal tractMedDRA version: 12.1Level: HLTClassification code 10025680Term: Malignant miscellaneous gastrointestinal neoplasmsEUCTR2009-009919-21-ITISTITUTO DERMOPATICO IMMACOLATA