Nab-Paclitaxel-based Re-induction Chemotherapy Followed by Response-stratified Chemoradiotherapy in Patients With Previously Treated Squamous Cell Carcinoma of the Head and Neck.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with fluorouracil, hydroxyurea, and radiation therapy, determined according to incidence of DLT graded using the National Cancer Institute (NCI) CTCAE 4.0
研究概览
简要总结
This phase I trial studies the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with carboplatin followed by chemoradiation in treating patients with recurrent head and neck cancer. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, carboplatin, fluorouracil, and hydroxyurea, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving paclitaxel albumin-stabilized nanoparticle formulation followed by chemoradiation therapy may be an effective treatment for head and neck cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) when given in combination with FHX (5 fluorouracil [fluorouracil], hydroxyurea and twice daily radiation, in good induction responders) and of nab-paclitaxel added to hypofractionated radiotherapy for poor responders.
II. To explore the feasibility of a more rapid palliative chemoradiotherapy approach inpatients with refractory disease as demonstrated by failure to respond to initial chemotherapy.
III. To explore the role of induction chemotherapy as a predictive tool for definitive head and neck cancer management of previously treated patients.
SECONDARY OBJECTIVES:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological documentation of recurrent head and neck cancer requiring regional therapy
- •Recurrent or second primary, previously irradiated squamous cell carcinoma of the head and neck (SCCHN) without clinically measurably metastatic disease
- •Prior radiation therapy completed >= 4 months, and/or chemotherapy completed >= 1 month before study entry, and patient should have recovered from any adverse effects
- •Predominance of disease that is amenable to radiotherapy
- •Measurable disease prior to induction chemotherapy
- •Eastern Cooperative Oncology Group performance status of one or less
- •Life expectancy of greater than 12 weeks
- •Women of childbearing potential and sexually active males must use an effective contraception method during treatment and for three months after completing treatment
- •Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of childbearing potential
- •Patients must have < grade 2 pre-existing peripheral neuropathy (per Common Terminology Criteria for Adverse Events [CTCAE])
- •Leukocyte >= 3,000/ul
- •Absolute neutrophil count >= 1,500/ul
- •Platelets >= 1000,000/ul
- •Total bilirubin =< 1.5 x institutional upper limit of normal
- •Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal
- •Creatinine clearance (CrCl) > 45 mL/min
排除标准
- •Previously untreated patients with locoregional-only disease are not eligible
- •Patients who have had chemotherapy within 4 weeks prior to entering the study, or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- •Patients may not be receiving any other investigational agents
- •History of allergic reactions attributed to compounds of similar chemical composition agents used in the study
- •Patients with pre-existing grade 2 or greater peripheral neuropathy, defined as sensory alteration or paresthesia (including tingling), interfering with function
- •Uncontrolled intercurrent illness including but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: carboplatin (Drug)
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: paclitaxel albumin-stabilized nanoparticle formulation (Drug)
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: fluorouracil (Drug)
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: hydroxyurea (Drug)
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: therapeutic conventional surgery (Procedure)
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: radiation therapy (Radiation)
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: hyperfractionated radiation therapy (Radiation)
Treatment (induction therapy and AFHX or AXX)
See Detailed Description
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with fluorouracil, hydroxyurea, and radiation therapy, determined according to incidence of DLT graded using the National Cancer Institute (NCI) CTCAE 4.0
时间窗: 4 weeks
Recommended phase II dose of paclitaxel albumin-stabilized nanoparticle formulation in combination with radiation therapy, determined according to incidence of DLT graded using the NCI CTCAE 4.0
时间窗: 4 weeks
次要结局
- PFS(The time from the date of registration to the date of progressive disease or death, assessed up to 1 year)
- Overall survival(The time from the date of registration to the date of death, assessed up to 1 year)
- Objective response rate (complete response [CR] + partial response [PR])(Up to 1 year)