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临床试验/NCT00851877
NCT00851877已完成1 期

A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2009年3月1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
入组人数
37
试验地点
2
主要终点
Phase I Maximum Tolerated Dose of Nab-Paclitaxel

研究概览

简要总结

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.

详细描述

OBJECTIVES:

Primary

  • To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)
  • To evaluate the disease-free survival of patients treated with this regimen. (Phase II)

Secondary

  • To identify dose-limiting toxicities in these patients treated with this regimen. (Phase I)
  • To assess the safety and tolerability of this regimen. (Phases I and II)
  • To assess progression-free survival and survival of patients treated with this regimen. (Phase I)
  • To assess overall survival in patients treated with this regimen. (Phase II)
  • To assess response rates in patients treated with this regimen. (Phases I and II)

研究设计

研究类型
Interventional
分配方式
Na
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 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

arm one

Experimental

Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy

干预措施: Cetuximab (Biological)

arm one

Experimental

Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy

干预措施: Cisplatin (Drug)

arm one

Experimental

Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy

干预措施: Nab-Paclitaxel (Drug)

arm one

Experimental

Nab-Paclitaxel, Cisplatin, Cetuximab, intensity-modulated radiation therapy

干预措施: intensity-modulated radiation therapy (Radiation)

结局指标

主要结局

Phase I Maximum Tolerated Dose of Nab-Paclitaxel

时间窗: 90 days

Seven participants were assigned nab-paclitaxel in dose of 25mg/m\^2. Five participants were assigned nab-paclitaxel in dose of 20mg/m\^2.

Phase II 2-year Progression-free Survival

时间窗: 2 year

Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The primary endpoint of 2-year progression-free survival was measured from the date of enrollment to the first occurrence of new metastatic lesion, objective tumor progression, or death.

次要结局

  • Phase II 2-year Local Control(2 year)
  • Phase II 2-year Overall Survival(2 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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