Open-label, Randomized, Controlled Phase I/II Study of Cilengitide to Evaluate the Safety and Efficacy of the Combination of Different Regimens of Cilengitide Added to Cisplatin, 5-FU, and Cetuximab in Subjects With Recurrent/Metastatic Squamous Cell Cancer of the Head and Neck
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS) Time: Investigator Read
研究概览
简要总结
The purpose of this open-label, randomized, controlled, Phase 1/2 study of the integrin inhibitor cilengitide is to evaluate the safety and efficacy of the combination of different regimens of cilengitide added to cisplatin, 5-fluorouracil (5-FU), and cetuximab in participants with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN).
The Phase 1 part was conducted in dedicated study centers. In the Phase 2 part of this trial, cilengitide is administered at two different doses to two experimental groups. The third group will only receive cisplatin, 5-FU and cetuximab. In the Phase 1 part of this trial, the dose of cilengitide in combination with cisplatin, 5-FU and cetuximab was determined.
Cilengitide is an experimental anti-cancer substance interacting with so-called integrins. Integrins are protein molecules that are known to be present on the surface of certain cancer cells. Integrins are also found on certain cells that belong to growing blood vessels (endothelial cells). Integrins potentially facilitate the blood vessels' support of the tumor (angiogenesis) as well as the tumor's growth and further spread throughout the body (metastasis). By inhibiting integrins on the tumor cell surface, cilengitide potentially kills cancer cells, and potentially sensitizes cancer cells to other co-administered therapeutics. By inhibiting integrins on the endothelial cell surface, it potentially inhibits the ingrowth of additional blood vessels towards the tumor.
Cilengitide is given as an intravenous infusion (given by a drip in one vein of your arm). If any unacceptable side effect occurs, treatment with the study drug will be stopped.
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
- 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 diagnosis of SCCHN
- •At least one measurable lesion either by computerized tomography (CT) scan or magnetic resonance imaging (MRI)
- •Karnofsky performance status (KPS) of greater than or equal to 70 or eastern cooperative oncology group performance status (ECOG PS) of 0-1 at trial entry
排除标准
- •Prior systemic chemotherapy, except if given as part of a multimodal treatment for locally advanced disease, which was completed more than 6 months prior to trial entry
- •Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
- •Nasopharyngeal Carcinoma
- •Documented or symptomatic brain or leptomeningeal metastasis
- •Previous treatment with epidermal growth factor receptor (EGFR) targeting therapy or signal transduction inhibitors
研究组 & 干预措施
Cilengitide 2000 mg once weekly+Cetuximab+5-FU+Cisplatin
干预措施: Cilengitide 2000 mg once weekly (Drug)
Cilengitide 2000 mg once weekly+Cetuximab+5-FU+Cisplatin
干预措施: Cetuximab (Drug)
Cilengitide 2000 mg once weekly+Cetuximab+5-FU+Cisplatin
干预措施: 5-fluorouracil (5-FU) (Drug)
Cilengitide 2000 mg once weekly+Cetuximab+5-FU+Cisplatin
干预措施: Cisplatin (Drug)
Cilengitide 2000 mg twice weekly+Cetuximab+5-FU+Cisplatin
干预措施: Cilengitide 2000 mg twice weekly (Drug)
Cilengitide 2000 mg twice weekly+Cetuximab+5-FU+Cisplatin
干预措施: Cetuximab (Drug)
Cilengitide 2000 mg twice weekly+Cetuximab+5-FU+Cisplatin
干预措施: 5-fluorouracil (5-FU) (Drug)
Cilengitide 2000 mg twice weekly+Cetuximab+5-FU+Cisplatin
干预措施: Cisplatin (Drug)
Cetuximab+5-FU+Cisplatin
干预措施: Cetuximab (Drug)
Cetuximab+5-FU+Cisplatin
干预措施: 5-fluorouracil (5-FU) (Drug)
Cetuximab+5-FU+Cisplatin
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression-free Survival (PFS) Time: Investigator Read
时间窗: Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011)
The PFS is defined as the duration from randomization until radiological progression (based on response evaluation criteria in solid tumors \[RECIST\] Version 1.0) or death due to any cause. Only deaths within 84 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment. Investigator read is the assessment of all imaging by the treating physician at the local trial site.
次要结局
- Overall Survival (OS) Time(Time from randomization to death, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011))
- Best Overall Response (BOR) Rate(Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011))
- Duration of Response(Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011))
- Disease Control Rate(Evaluations will be performed every 6 weeks until progression reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011))
- Time to Treatment Failure (TTF)(Time from randomization to disease progression, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011))
- Safety - Number of Participants Experiencing Any Adverse Event(Time from first assessment of CR or PR until PD, death or last tumor assessment, reported between day of first participant randomized, 03 July 2009, until cut-off date (03 September 2011))