NCT00572078已完成1 期
Phase I Dose-Escalation Drug-Interaction Study of Sorafenib and Bevacizumab in Combination With Paclitaxel in Patients With Solid Tumors
Safi Shahda1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2008年1月23日最近更新:
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
- 27
- 试验地点
- 1
- 主要终点
- To evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors.
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological diagnosis of a solid tumor with evidence of residual, recurrent, or metastatic disease. Patients must be incurable by surgical or other standard available therapy
- •Measurable or evaluable disease; tumor size of ≥ 2 cm on CT scan
- •Patients may have received prior standard taxane therapy or anti-VEGF therapy, but may not have progressed on both therapies. Progression on one type therapy (either taxane or anti-VEGF) is allowed
排除标准
- •History or presence of central nervous system (CNS) disease (i.e., primary brain tumor, malignant seizures, CNS metastases or carcinomatous meningitis).
- •Prior chemotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- •Prior biologic or immunotherapy ≤ 3 weeks prior to registration. Patients must have recovered from all therapy-related toxicities
- •Prior full pelvic field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization. Patients must have recovered to less than or equal to grade 1 from all therapy-related toxicities except alopecia. The site of previous radiotherapy should have evidence of progressive disease if this is the only site of evaluable disease
- •Major surgery (i.e., laparotomy) ≤ 4 weeks prior to randomization or anticipation of need for major surgical procedure during the course of the study
- •Minor surgery ≤ 2 weeks prior to randomization. Insertion of a vascular access device is not considered major or minor surgery in this regard. Patients must have recovered from all surgery-related toxicities
- •Peripheral neuropathy with functional impairment ≥ Common Terminology Criteria (CTC) grade 2 neuropathy, regardless of causality
- •Pleural effusion or ascites that causes respiratory compromise (≥ CTC grade 2 dyspnea)
- •Concurrent severe and/or uncontrolled cardiac, vascular or infectious conditions (as described in the protocol) which could compromise participation in the study
- •Patients at risk of QT prolongation such as patients with congenital long QT syndrome or with long corrected QT (QTc) at baseline (i.e. QTc greater than 450 msec in males, and greater than 470 msec in females) will be excluded
- •Lung carcinoma of squamous cell histology (mixed tumors will be categorized by the predominant cell type unless small cell elements are present, in which case the patient is ineligible; sputum cytology alone is not acceptable).
研究组 & 干预措施
Sorafenib, Bevacizumab & Paclitaxel
Experimental
Paclitaxel is given as i.v infusion over 60 min on days 1, 8, 15 every 28 days. Sorafenib is given orally starting with cycle 1 day 2. Bevacizumab is given as i.v infusion on days 1 and 15 every 28 days.
干预措施: Sorafenib (Drug)
结局指标
主要结局
To evaluate the safety and tolerability and describe the maximum tolerated dose (MTD) of treatment with escalating doses of sorafenib in combination with bevacizumab and paclitaxel for patients with advanced solid tumors.
时间窗: baseline through end of treatment
次要结局
- To evaluate the pharmacokinetics of paclitaxel and sorafenib alone and in combination(baseline through end of treatment)
- To evaluate pharmacodynamic changes a)in tumor vascular parameters and b)in plasma VEGF and soluble VEGF receptor levels, and correlate with clinical outcomes and sorafenib pharmacokinetic (PK) profile.(baseline through end of treatment)
- To evaluate variants in genes of paclitaxel drug-metabolism and drug-transporters P glycoprotein and correlate with PK profile for paclitaxel and with clinical outcomes(baseline through end of treatment)
研究者
Safi Shahda
Principal Investigator
Indiana University School of Medicine
研究点 (1)
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