NCT00661739已完成1 期
A Multicentre Phase I-II Study to Investigate the Combination of Bendamustine With Weekly Paclitaxel as First or Second Line Therapy in Patients With Metastatic Breast Cancer
German Breast Group0 个研究点目标入组 38 人开始时间: 2005年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel.
研究概览
简要总结
The aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. The two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. The combination might be of special interest for elderly patients with hormone insensitive breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures;
- •Pathological confirmed primary carcinoma of the breast.
- •Locally advanced or metastatic disease
- •Up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. Previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial.
- •Patients must have either measurable or non-measurable lesions according to the WHO criteria
- •At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease.
- •Complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated
- •Karnofsky-Index ≥ 60 %
- •Age ≥ 18 years
- •Absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥ 9 g/dl
- •Bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit
- •Serum creatinine ≤ 2.0 mg/dl
- •Normal left ventricular ejection fraction (LVEF) by echocardiogramme
- •Patients of childbearing potential, pregnancy test must be negative
- •If fertile effective contraception must be used throughout the study
排除标准
- •Known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances;
- •Concurrent immunotherapy or hormonal treatment for cancer (Bisphosphonates may be continued)
- •Symptomatic parenchymal brain metastases not responding to treatment
- •Life expectancy less than 3 months
- •Other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study
- •Concurrent treatment with other experimental drugs or any other anti-cancer therapy within the last 28 days;
- •History of congestive heart failure or other significant uncontrolled cardiac disease
- •Pregnant or nursing women
研究组 & 干预措施
Singular Arm
Experimental
Bendamustine treatment
干预措施: Bendamustine (Drug)
结局指标
主要结局
The phase I part of the trial should evaluate the maximal tolerated dose (MTD) for the combination of bendamustine with paclitaxel.
时间窗: end of cycle 2 of the 6th patient of the assumed highest dose level
次要结局
- To determine the objective response rate (phase II part)(EOT last patient (phase II part))
研究者
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