NCT00499291撤回不适用
Pharmacokinetic, Pharmacodynamic and Pharmacogenetic Study of Nab-Paclitaxel (Nanoparticle Albumin Bound-Paclitaxel) in Patients With Advanced Solid Tumors
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Inter-individual pharmacokinetic variability
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This clinical trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with advanced or refractory solid tumors.
详细描述
OBJECTIVES:
Primary
- To develop a population pharmacokinetic model for paclitaxel administered as paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) to a large population of patients with advanced or refractory cancer to characterize the inter-individual pharmacokinetic variability of this agent.
Secondary
- To explore nab-paclitaxel pharmacokinetic parameters in patients with metastatic prostate cancer (castrate), metastatic breast cancer, advanced non-small cell lung cancer and other incurable advanced or refractory tumors amenable to treatment with nab-paclitaxel.
- To explore the association between exposure to total and unbound paclitaxel after administration of nab-paclitaxel and neutropenia.
- To explore the association between the CYP2C8*3 variant and paclitaxel clearance.
- To explore the association between other variants of CYP2C8 and other genes involved in paclitaxel disposition including CYP3A4, CYP3A5, SLCO1B3 (OATP8), and ABCB1 (MDR1) and paclitaxel pharmacokinetic parameters and toxicity after one course of treatment.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Patients must have an incurable advanced or refractory tumor amenable to treatment with paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel)
- •Per the National Comprehensive Cancer Network, the following cancer sites have been shown to be responsive to taxane therapy:
- •Prostate cancer
- •Breast cancer
- •Non-small cell lung cancer
- •Bladder cancer
- •Head and neck cancer
- •Oral cancer
- •Cervical cancer
- •Ovarian cancer
- •Endometrial cancer
- •Esophageal cancer
- •Gastric cancer
- •Germ cell tumors
- •Tumors of unknown primary
- •Soft tissue sarcomas
- •Small cell lung cancer
- •Testicular cancer
- •Upper genitourinary tract cancers
- •PATIENT CHARACTERISTICS:
- •Patients must have performance status 0-2 by the ECOG scale
- •Absolute neutrophil count ≥ 1,500/μL
- •Platelet count ≥ 100,000/μL
- •Hemoglobin ≥ 9 g/dL
- •Bilirubin ≤ institutional upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 x ULN
- •Alkaline phosphatase ≤ 2.5 x ULN (if bone metastasis is present in the absence of liver metastasis, alkaline phosphatase must be ≤ 5 x ULN)
- •Creatinine ≤ 1.5 x ULN
- •Patients must not have baseline sensory neuropathy ≥ grade 2
- •Women must not be pregnant or breastfeeding
- •Negative blood or urine pregnancy test
- •Women of childbearing potential and sexually active males must agree to use an accepted and effective method of contraception
- •PRIOR CONCURRENT THERAPY:
- •Prior treatment is allowed, which may include prior taxane therapy
- •If patient has had prior therapy(ies), s/he must have received last treatment ≥ 28 days prior to registration
- •Patients must not be receiving colony stimulating factors (CSFs)
- •Previous CSFs must have been discontinued > 14 days prior to registration
- •Patients must not be receiving concomitant treatment with any of the following (prior use is allowed, but must have been discontinued ≥ 28 days prior to registration):
- •Phenytoin
- •Carbamazepine
- •Barbiturates
- •Rifampicin
- •Phenobarbital
- •Hypericum perforatum (St. John's wort)
- •Ketoconazole
排除标准
- 未提供
结局指标
主要结局
Inter-individual pharmacokinetic variability
次要结局
- CYP2C8*3 variant expression
- Pharmacokinetic parameters
- Neutropenia
- Genetic variance relating to pharmacokinetics and toxicity
研究者
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