A Single Center Phase IIa Study of Nanoparticle Albumin-bound Paclitaxel in Combination With Cisplatin in Advanced Nasopharyngeal Carcinoma
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a single center, non-randomized phase IIa study to determine the tolerance and safety of Abraxane (ABX) in combination with cisplatin (DDP) in patients with advanced nasopharyngeal carcinoma (NPC). Patients in whom the standard therapy had failed or had been infeasible will be eligible.The safety and efficacy will be evaluated according to NCI-CTCAE V4.0 and RECIST 1.1 respectively.
详细描述
Nasopharyngeal carcinoma (NPC) is most commonly seen in Southeast Asia, especially in southern and southeastern China, where the incidence rate has been documented between 10 and 150 cases per 100,000 population per year. For advanced or metastatic NPC, chemotherapy remain the mainstay of treatment. The 130-nm albumin-bound formulation of paclitaxel ([Abraxane, ABX ];Celgene,Summit,NJ) is a promising new agent with more efficient entry to the tumor microenvironment via caveolae-mediated transcytosis and preferential uptake by cancer cells. Superior activity of ABX-based regimens without the necessity for antianaphylactic pretreatments been shown in various solid tumors compared with the traditional solvent-based paclitaxel-based ones. However, the safety and efficacy of combination of ABX and cisplatin (DDP) has not been determined in patients with advanced NPC. In this single center, non-randomized phase IIa study, investigators seek to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of ABX-DDP, and perform an exploratory study of its efficacy as measured by tumor response.
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
- •Histologically proven NPC diagnosis
- •Patients who failed the prior standard treatment or were intolerant of standard treatment
- •Elder than 18 years old
- •Performance status 0-2
- •Patients previously treated with chemotherapy (those having received paclitaxel-based regimen were not excluded)
- •Subjects with at least one measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable).
- •Life expectancy over twelve weeks
- •Neutrophil > 1.5X10^9/L, PLT > 100X10^9/L, Hb ≥ 90 g／l, with normal hepatic function(AST, ALT < 2.5 x upper limit of normal , and bilirubin < 1.0 x upper limit of normal), with normal renal function (creatinine < 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min as calculated by the Cockcroft - Gault formula. )
- •Urine pregnancy test (-) within 1 weeks before enrollment or being able to take effective contraceptive measures during the medication and six months after completion of the trial for fertile women.
- •Being able to provide paraffin blocks or 5-7 slides of biopsy tumor tissues.
- •Amenable to regular follow-up and to comply with trial requirements.
- •Signed and dated informed consent before the start of specific protocol procedures
排除标准
- •History of allergy to paclitaxel or docetaxel
- •Patient with central nervous system metastasis
- •Patient refusing participation or signing informed consent
- •Active clinically serious infections with an anticipated antibiotics treatment for more than 4 weeks
- •Patient with life threatening medical condition such as congestive heart failure, symptomatic coronary artery disease or heart block
- •Myocardial infarction that occurred within 3 months before enrollment
- •Had received chemotherapy, radiotherapy or other anti-cancer therapies within 3 weeks before enrollment
- •With a pre-existing peripheral neuropathy (National Cancer Institute Common Toxicity Criteria for Adverse Events [NCI CTC] grade ≥ 2)
- •Previously received post-2nd line anti-cancer therapy
- •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors[Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- •History of immunodeficiency , including HIV testing positive or suffering from other acquired and congenital immunodeficiency disease, or the history of organ transplants;
- •Patients receiving prior abraxane treatment during pregnancy or lactation period
- •Fertile women who failed to or are reluctant to take contraceptive measures or pregnancy test
- •Men or his companion who are reluctant to take effective contraceptive measures during the medication and six months after completion of the trial
研究组 & 干预措施
1-day regimen
ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
干预措施: ABX + DDP (Drug)
2-day regimen
ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
干预措施: ABX + DDP (Drug)
3-day regimen
ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
干预措施: ABX + DDP (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: 24 months
次要结局
- Progression free survival (PFS)(24 months)
- Number of Participants with Adverse Events(24 months)
研究者
Li Zhang
Professor
Sun Yat-sen University