NCT00028873已完成2 期
An EORTC-IDBBC/ECSG Phase II Study Evaluating The Role Of The Multi-Drug Resistance (MDR) Reversor, R101933, In Patients With Taxane Refractory Metastatic Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC2 个研究点 分布在 2 个国家目标入组 35 人开始时间: 2001年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor cells to be killed.
PURPOSE: Phase II trial to study the effectiveness of combining R101933 with either paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy.
详细描述
OBJECTIVES:
- Determine the activity of R101933 in combination with paclitaxel or docetaxel in terms of response to treatment and level of clinical benefit in patients with taxane-refractory metastatic breast cancer.
- Determine the safety of this regimen in these patients.
- Determine the acute side effects in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive R101933 IV over 1 hour immediately followed by paclitaxel IV over 3 hours or docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. Patients who have no disease progression after 7 courses may continue with treatment at the investigator's discretion.
Patients are followed every 6 weeks until disease progression.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed metastatic breast cancer
- •Received at least 2 prior courses of paclitaxel-based chemotherapy at doses between 175-200 mg/m^2 (given over 3 hours every 3 weeks) or docetaxel-based chemotherapy at doses between 75-100 mg/m^2 (given over 1 hour every 3 weeks) as most recent anticancer therapy
- •Evidence of disease resistance
- •Progressive disease as best response OR
- •Transient response or disease stabilization followed by progression during taxane-based treatment
- •Disease progression on a combination of a taxane and another cytotoxic agent allowed
- •Unidimensionally measurable disease
- •At least 1 target lesion that clearly progressed or developed during prior taxane therapy
- •Lesions stable or responsive to prior taxane therapy are not considered target lesions
- •Lesions that have been irradiated within the past 3 months are not considered target lesions unless they have clearly progressed or appeared since radiotherapy
- •No bone metastases as only site of measurable disease
- •No rapidly progressive visceral metastases
- •No symptomatic CNS metastases
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Not specified
- •Menopausal status:
- •Not specified
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Transaminases no greater than 2.5 times ULN (5 times ULN if liver metastases present)
- •Creatinine no greater than 1.5 times ULN
- •Calcium normal
- •Cardiovascular:
- •LVEF normal by echocardiogram (ECG) or MUGA scan
- •QTc less than 450 sec on baseline ECG
- •No prior clinically significant arrhythmias requiring treatment
- •No cardiac infarction
- •No atrial ventricular enlargement or hypertrophy
- •No prior toxicity to paclitaxel that would preclude study dose and schedule
- •Sodium, potassium, chloride, and bicarbonate normal
- •No pre-existing neuropathy greater than grade 2
- •No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer or cancer that has been in remission for more than 5 years
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent anticancer biologic agents
- •Chemotherapy:
- •See Disease Characteristics
- •No more than 8 weeks since last course of prior taxane-based chemotherapy
- •No more than 2 prior chemotherapy regimens for metastatic breast cancer
- 另有 12 项未显示
排除标准
- 未提供
研究者
研究点 (2)
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