NCT01412229已完成2 期
A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Clinical Response Rate Following Induction Chemotherapy
研究概览
简要总结
This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.
详细描述
This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.
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
- •Histologically or cytologically confirmed SCCHN or poorly differentiated or undifferentiated cancer of the head and neck.
- •Measurable disease.
- •All primary sites are eligible excluding nasopharyngeal.
- •Surgically unresectable and/or N2b or greater nodal disease; Note: surgical unresectability will be defined as the combination of the treating surgeon's judgment of unresectability plus one of the following objective criteria:
- •Encasement of tumor or nodes to the carotid artery or ¾ encasement of the carotid artery.
- •Involvement of prevertebral musculature
- •Invasion of the bone of the skull base
- •Need for glossectomy or extensive glossal resection where functional outcome is considered unacceptable to surgeon or patient
- •Involvement of the cervical spine
- •Severe, unacceptable functional deficit that would result from any proposed definitive surgical resection.
- •ECOG performance status 0-1
- •Prior therapy:
- •Chemotherapy: No prior chemotherapy for the treatment of SCCHN.
- •Platinum chemotherapy: No previous history of carboplatin or cisplatin therapy.
- •Nab-paclitaxel: No previous treatment with nab-paclitaxel or another taxane.
- •Cetuximab: No previous treatment with cetuximab Or another epidermal growth factor receptor (EGFR) inhibitor.
- •Radiation therapy: No prior radiation to the head and neck region.
- •Age > or = 18 years. Men and women are eligible for participation.
- •Must have acceptable organ and marrow function as defined below. Laboratory tests should be completed within 14 days prior to registration:
- •Absolute Neutrophil Count (ANC) > or = 1,500/mm3
- •Platelets > or = 100,000/mm3
- •Hemoglobin (Hgb) > 9g/dL
- •Total bilirubin < or = 1.5mg/dL
- •Albumin > 2.5 g/dL
- •Aspartate aminotransferase (AST)/Alanine Aminotransferase (ALT) < or = 2.5 times institutional upper limit of normal, alkaline phosphatase < 2.5 x upper limit of normal, glomerular filtration rate (GFR) > 30 mL/min (by standard Cockcroft and Gault formula or measured via 24 hour urine collection)
- •No pre-existing neuropathy greater than grade I
- •Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to day 1 of study treatment.
- •Women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation and for three months after completing treatment. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
- •Patients must have the ability to understand and the willingness to sign a written informed consent document.
- •Patients must have a negative result for preformed immunoglobulin E (IgE) antibodies to galactose-alpha-1,3,-galactose.
排除标准
- •Prior treatment with any of the study medications.
- •Prior radiation to any of the field required to treat the tumor.
- •Any metastatic disease.
- •The patient may have had a prior malignancy but must be disease-free for three years prior to study entry. A history of superficial non-melanoma skin cancer or in situ carcinoma of the cervix less than three years will be allowed.
- •Pregnant or lactating female
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring IV antibiotics, or psychiatric illness/social situations that would limit compliance with study requirements. Cardiac disease such as symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction will result in exclusion only if active within the past six months. Cardiac dysrhythmia will only result in exclusion if active and symptomatic (for example, rate-controlled atrial fibrillation will not result in exclusion).
研究组 & 干预措施
Treatment
Experimental
- nab-paclitaxel 100mg/m2
- Carboplatin area under curve (AUC)2 (IV)
- Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
干预措施: Cetuximab (Drug)
Treatment
Experimental
- nab-paclitaxel 100mg/m2
- Carboplatin area under curve (AUC)2 (IV)
- Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
干预措施: Nab-paclitaxel (Drug)
Treatment
Experimental
- nab-paclitaxel 100mg/m2
- Carboplatin area under curve (AUC)2 (IV)
- Cetuximab 400mg/m2 week 1 then 250mg/m2 for six weeks
干预措施: Carboplatin (Drug)
结局指标
主要结局
Clinical Response Rate Following Induction Chemotherapy
时间窗: 9 weeks
Evaluation of target lesions via imaging with CT or MRI scans at 2-3 weeks post induction chemotherapy. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.
次要结局
- Rate of Complete Response Following Induction Chemotherapy(Baseline evaluation to 3 weeks after induction chemotherapy)
- Number of Participants With at Least One Grade 3-4 Toxicity, Listed by Event(24 Weeks)
- Objective Response Rate (CR+PR)(20 weeks)
- Complete Response Rate (CR)(20 weeks)
- Progression Free Survival(1 year)
- Overall Survival(1 year)
- Number of Participants With at Least One Grade 3-4 Toxicity(9 Weeks)
- Patient-reported Quality of Life Scores(screening until one year after treatment)
研究者
研究点 (3)
Loading locations...
相似试验
已完成
不适用
Phase II trial of nab-paclitaxel and carboplatin with concurrent radiotherapy for patients with locally advanced non-small cell lung cancernon-small cell lung cancerJPRN-UMIN000019611Department of Radiation Oncology, Yamaguchi University Hospital37
已完成
1 期
Phase I/II trial of nab-Paclitaxel,Carboplatin,plus Bevacizumab chemotherapy for patients with advanced Non-Squamous Non-Small Cell Lung Cancer.Advanced Non-Squamous Non-Small Cell Lung CancerJPRN-UMIN000013201Cancer Institute Hospital of JFCR61
终止
2 期
Carboplatin-Paclitaxel Adjuvant Chemotherapy in the Treatment of Locally Advanced Cervical CancerLocally Advanced CancerCervical CancerNCT04016142Centre Oscar Lambret21
招募中
2 期
OGIK2102JPRN-jRCTs071220008Okamoto Isamu52
进行中（未招募）
2 期
Nab-Paclitaxel + Cisplatin + Gemcitabine in Untreated Metastatic Pancreatic AdenocarcinomaPancreatic Ductal AdenocarcinomaNCT03915444HonorHealth Research Institute42