A Randomized Open-Labeled Phase II Study of Combretastatin A-4 Phosphate in Combination With Paclitaxel and Carboplatin to Evaluate the Safety and Efficacy in Subjects With Advanced Imageable Malignancies
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies
研究概览
简要总结
This is a study evaluating the safety and effectiveness of Combretastatin A4 Phosphate (CA4P) combined with the chemotherapy drugs, carboplatin and paclitaxel. The full treatment and observation time should be about 5 months. During this time the patient should receive 18 CA4P infusions and 6 carboplatin followed by paclitaxel treatments. Patients will be randomized into one of two CA4P dose-level groups in order to recommend a preferred dose-level for future studies. At least 2 dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) scans will be conducted to monitor the blood flow through the tumor before and after treatment with CA4P.
详细描述
This is a phase II study evaluating the safety and efficacy of Combretastatin A4 Phosphate (CA4P) combined with carboplatin and paclitaxel. Treatment is for a maximum of 6 consecutive 21-day cycles. Patients are randomized onto one of two CA4P dosing arms (45 or 63 mg/m2). CA4P is administered on days 1, 8 and 15 of each cycle. Carboplatin and paclitaxel (AUC 6 and 200 mg/m2, respectively) are administered on day 2 of each cycle. At least 2 DCE-MRI scans will be performed to evaluate the change in tumor blood flow following treatment with CA4P.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Advanced malignancy where treatment with carboplatin and paclitaxel is warranted.
- •Minimum 28-day interval from any surgical, chemotherapy or immunotherapy treatment and a 14-day interval from radiotherapy treatment.
- •Radiologically measurable disease to meet MRI perfusion criteria.
- •ECOG performance status less than or equal to
- •Life expectancy greater than 12 weeks.
- •Normal ejection fraction.
排除标准
- •Uncontrolled brain metastasis.
- •Significant cardiac abnormalities.
- •Prior radiotherapy at the tumor site.
- •Symptomatic peripheral vascular or cerebrovascular disease.
- •Uncontrolled hypertension.
研究组 & 干预措施
45 mg/m2 Combretastatin A-4 Phosphate
干预措施: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin (Drug)
60 mg/m2 Combretastatin A-4 Phosphate
干预措施: Combretastatin A-4 Phosphate + Paclitaxel + Carboplatin (Drug)
结局指标
主要结局
To assess safety of the CA4P-paclitaxel-carboplatin combination in advanced imageable malignancies
时间窗: From first administration of study drug through approximately 30 days following last dose of study drug
To establish the Recommended Phase II Dose (RP3D) for the combination of CA4P-paclitaxel-carboplatin in advanced imageable malignancies
时间窗: from first study drug administration through end of study visit
To evaluate tumor response
时间窗: From baseline through end of study visit
To assess the change in tumor blood flow by use of MRI in advanced imageable malignancies
时间窗: from screening through end of study visit
次要结局
未报告次要终点