A Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Palifermin (Recombinant Human Keratinocyte Growth Factor) for Reduction of Oral Mucositis in Subjects With Stage 2B or 3 Locally Advanced, Colon Cancer Receiving 5-FU and Leucovorin as Adjuvant Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 100
- 主要终点
- Incidence of Grade ≥ 2 (WHO scale) oral mucositis
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability of palifermin (recombinant human keratinocyte growth factor, rHuKGF) in reducing the incidence of oral mucositis in subjects with stage 2B and 3 locally advanced, colon cancer receiving chemotherapy as an adjuvant treatment for their disease.
详细描述
This study is being conducted to determine whether administration of a single IV dose of palifermin 3 days before initiation of chemotherapy and 3 days before each subsequent treatment cycle would reduce the incidence of oral mucositis and to evaluate the safety profile in the subject population. This study will evaluate the efficacy of palifermin in reducing the incidence of grade ≥ 2 OM in subjects with stage 2B or stage 3 locally advanced, colon cancer undergoing adjuvant chemotherapy with 5-FU and leucovorin in cycle 1. This study will also assess the safety and tolerability of palifermin administered as a single IV dose before each cycle of 5-FU and leucovorin, evaluate the effect of palifermin on patient-reported mouth and throat soreness, the incidence of grade ≥ 2 oral mucositis in cycle 2, the duration of grade ≥ 2 oral mucositis, 5-FU dose reductions/delays and the long-term effects of palifermin on disease outcome and survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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 newly diagnosed histologically confirmed resected colon cancer (American Joint Committee on Cancer [AJCC] Stage 2B or 3) and a candidate for adjuvant 5-FU and Leucovorin
- •Eastern Cooperative Oncology Group performance status ≤ 1
- •Functional hematopoietic and hepato-renal systems
排除标准
- •Previous therapy (e.g. chemotherapy, radiotherapy or biological therapy) for colon cancer, other than surgical tumor resection
- •Presence or history of any other primary malignancy
- •Presence of active or chronic oral mucositis or xerostomia
- •Previous treatment with other keratinocyte growth factors
研究组 & 干预措施
Palifermin
50 subjects to receive palifermin 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.
干预措施: palifermin (Drug)
Control Group
50 subjects to receive matched placebo 3 days prior to the first day (day 1) of each cycle of 5-FU/ LV chemotherapy.
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of Grade ≥ 2 (WHO scale) oral mucositis
时间窗: in Cycle 1 of chemotherapy treatment phase
次要结局
- Incidence of chemotherapy (5-FU) dose reductions and dose delays(in Cycle 2 of chemotherapy treatment phase)
- Changes in laboratory values(during Treatment Phase (6 cycles of chemotherapy))
- Duration of grade ≥ 2 (WHO scale) oral mucositis(in Cycle 1 and in Cycle 2 of chemotherapy treatment phase)
- Incidence and severity of adverse events(during Treatment Phase (6 cycles of chemotherapy))
- Overall survival (OS)(within long-term follow-up phase)
- Incidence of grade ≥ 2 (WHO scale) oral mucositis(in Cycle 2 of chemotherapy treatment phase)
- Incidence of serum anti-palifermin antibody formation(during Treatment Phase (6 cycles of chemotherapy))
- Progressive disease rate(at 6 months)
- Average mouth and throat soreness (MTS) score(in Cycle 1 and in Cycle 2 of chemotherapy treatment phase)
- Incidence of other malignancies(within long-term follow-up phase)
- Incidence of secondary primary tumors(within long-term follow-up phase)
- Progression-free survival (PFS)(within long-term follow-up phase)