Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Weekly Doses of Palifermin (rHuKGF) for the Reduction of Oral Mucositis in Subjects With Advanced Head and Neck Cancer Receiving Adjuvant Radiotherapy and Chemotherapy(RT/CT)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 241
- 主要终点
- Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of severe oral mucositis in subjects with locally advanced head and neck cancer receiving radiotherapy with concurrent chemotherapy as adjuvant treatment for their disease.
详细描述
This study is being conducted to evaluate the efficacy of palifermin administered intravenously (IV) in weekly doses (minimum of 7 weekly doses, until RT was complete) in reducing the incidence of severe (World Health Organization [WHO] grade 3 or 4) oral mucositis in subjects with locally advanced HNC receiving RT concurrent with CT (RT/CT) as adjuvant treatment for their disease (postoperative setting). This study will assess the safety and tolerability of palifermin at the dose of 120 μg/kg IV administered weekly (minimum 7 weekly doses, until RT was complete) in this subject population. This study will also evaluate the effect of palifermin on the clinical sequelae of severe OM (eg, average subject-reported mouth and throat soreness [MTS] score), and on RT-induced xerostomia in this population, as well as the long-term effects of palifermin on disease outcome and survival in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •History of histologically documented squamous cell carcinoma ( AJCC [American Joint Committee on Cancer] Stage II, III, IVA or IVB) involving either the oral cavity, oropharynx, hypopharynx, or larynx,post surgical resection (R0, R1) and candidates for adjuvant RT/CT
- •Radiation treatment field to receive planned dose of at least 50Gy to area of the oral cavity/oropharynx mucosa that can be visualized
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
- •Functional hematopoietic and hepato-renal systems
排除标准
- •Tumors of the lips, paranasal sinuses, salivary glands, or unknown primary tumors
- •Metastatic disease (M1) Stage IV C
- •Presence or history of any other primary malignancy (other than curatively treated in situ cervical cancer or basal cell carcinoma of the skin)
- •History of chronic pancreatitis or episode of acute pancreatitis within the last year
- •Prior radiation to the site of the disease, or prior chemotherapy-
研究组 & 干预措施
Palifermin
Single IV dose of palifermin at 120 μg/kg, 3 days before the start of radiotherapy plus 6 once weekly palifermin doses at the same dose level during a 6-week Radiotherapy / chemotherapy course
干预措施: Palifermin (Drug)
Placebo
Single IV dose of placebo at 120 μg/kg, 3 days before the start of Radiotherapy, plus 6 once weekly placebo doses at the same dose during a 6-week radiotherapy / chemotherapy course.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence percentage of severe oral mucositis (Grades 3 or 4 on the WHO oral mucositis scale)
时间窗: Up to 24 weeks
次要结局
- Time to onset of severe oral mucositis (WHO Grades 3 or 4)(12 weeks)
- Incidence of >/equal to 5 missed consecutive fractions of scheduled RT (to include discontinuations of RT)(12 weeks)
- Average patient-reported mouth and throat soreness score (as reported on Question 3 of the Oral Mucositis Weekly Questionnaire for patients with Head and Neck cancer [OMWQ-HN](16 weeks)
- Total dose of opioid analgesics used (mg of morphine equivalents)(16 weeks)
- Duration of severe oral mucositis (WHO Grades 3 or 4)(15 weeks)
- Incidence of unplanned delays in CT for cisplatin administration on Day 22 (to include discontinuations of CT)(12 weeks)
- Incidence of xerostomia (CTCAE v3.0 Dry Mouth/Xerostomia scale Grade 2 or higher)(10 years)