NCT00446446已完成2 期
Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent 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
- 发起方
- Amgen
- 入组人数
- 52
- 主要终点
- Objective Response Rate
研究概览
简要总结
To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).
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 squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using computed tomography (CT) or magnetic resonance imaging (MRI) scan
- •Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
- •Karnofsky Performance Status (KPS) score ≥ 60% at screening
- •Men or women age ≥18 years
- •Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test
排除标准
- •Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
- •Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
- •Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
- •History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
- •Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
- •Known allergy or hypersensitivity to any component of panitumumab
- •Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions:
- •Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed > 24 weeks prior to randomization
- •Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
- •Significant thromboembolic event ≤ 8 weeks prior to enrollment
- •Subjects not recovered from all previous acute radiotherapy-related toxicities
- •History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
- •History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
- •Subject is currently in a clinical trial ≤ 30 days prior to enrollment
- •Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
- •Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
- •Female subject who is pregnant or breast-feeding
- •Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.
研究组 & 干预措施
Panitumumab
Experimental
articipants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
干预措施: Panitumumab (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: From first dose of study drug until the data cut-off date of 16 December 2010. Median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).
Assessments are based on investigator's review of scans using a modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Objective response rate was defined as the percentage of participants with a best tumor response of complete response (CR) or partial response (PR) prior to initiation of subsequent anti-cancer therapy. CR or PR was confirmed no less than 28 days after the criteria for response were first met. CR: Disappearance of all target lesions, non-target lesions and no new lesions. PR: At least a 30% decrease in the size of target lesions and no progression of existing non-target lesions (defined as an increase in lesion size of ≥ 20%) and no new lesions, or, the disappearance of all target lesions and the persistence of one or more non-target lesion(s) not qualifying for either CR or progressive disease (PD) and no new lesions.
次要结局
- Rate of Disease Control(From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).)
- Time to Progression(From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).)
- Progression Free Survival (PFS)(From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).)
- Time to Response(From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks))
- Duration of Response(From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks))
- Overall Survival (OS)(From first dose until the data cut-off date of 16 December 2010; median duration of treatment was 9.0 weeks (range: 3.0 to 68.9 weeks).)
- Number of Participants With Adverse Events(The reporting time frame for Adverse Events is from first dose date to 30 days since the last dose date date. The median time frame is 2.4 months.)
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