NCT00460265已完成3 期
A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 658
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of this study is to determine the treatment effect of Panitumumab in combination with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or recurrent squamous cell carcinoma of the head and neck.
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
- •Man or woman at least 18 years old.
- •Histologically or cytologically confirmed metastatic and/or recurrent squamous cell carcinoma (or its variants) of the head and neck.
- •Diagnosis of metastatic disease and/or recurrent disease following locoregional therapy and determined to be incurable by surgery or radiotherapy.
- •Subjects who have received radiation as primary therapy are eligible if locoregional recurrence is in the field of radiation and has occurred ≥6 months after the completion of radiation therapy. Subjects whose locoregional recurrence is solely outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months after the completion of radiation therapy.
- •Measurable and non-measurable disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
排除标准
- •History or known presence of Central Nervous System (CNS) metastases.
- •History of another primary cancer, except: curatively treated in situ cervical cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 2 years before randomization.
- •Nasopharyngeal carcinoma.
- •Prior systemic treatment for metastatic and/or recurrent SCCHN
- •Prior cisplatin containing induction chemotherapy followed by cisplatin containing chemoradiotherapy
- •Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with small molecule EGFr inhibitors
- •Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than or equal to 1 year prior to randomization. History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan.
- •Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
- •Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])
研究组 & 干预措施
ARM 2
Active Comparator
Arm 2 consists of Cisplatin and 5-FU
干预措施: ARM 2 (Drug)
ARM 1
Experimental
ARM 1 Consists of Panitumumab plus Cisplatin and 5-FU
干预措施: ARM 1 (Drug)
结局指标
主要结局
Overall Survival
时间窗: Upto 56 months
Time from randomization to death
次要结局
- Duration of Response(Every 6 weeks until disease progression, up to 56 months)
- Time to Progression(Every 6 weeks until disease progression, up to 56 months)
- Time to Response(Every 6 weeks until disease progression, upto 56 months)
- Progression Free Survival(Every 6 weeks until disease progression or deaths, upto 56 months)
- Overall Response Rate(Every 6 weeks until disease progression, up to 56 months)
研究者
相似试验
进行中（未招募）
3 期
Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing SarcomaMetastatic Ewing SarcomaMetastatic Malignant Neoplasm in the BoneMetastatic Malignant Neoplasm in the Bone MarrowMetastatic Malignant Neoplasm in the LungMetastatic Peripheral Primitive Neuroectodermal Tumor of BonePeripheral Primitive Neuroectodermal Tumor of Soft TissuesNCT02306161National Cancer Institute (NCI)312
进行中（未招募）
3 期
Combination Chemotherapy With or Without Blinatumomab in Treating Patients With Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic LeukemiaB Acute Lymphoblastic Leukemia, Philadelphia Chromosome NegativeAcute Lymphoblastic LeukemiaNCT02003222National Cancer Institute (NCI)488
已完成
2 期
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast CancerBreast CancerNCT01036087M.D. Anderson Cancer Center47
进行中（未招募）
3 期
A Study to Evaluate Chemotherapy Plus Osimertinib Against Chemotherapy Plus Placebo in Patients With Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung CancerNCT04765059AstraZeneca98
已完成
2 期
Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With BevacizumabMucinous Adenocarcinoma of the ColonMucinous Adenocarcinoma of the RectumRecurrent Colon CancerRecurrent Rectal CancerSignet Ring Adenocarcinoma of the ColonSignet Ring Adenocarcinoma of the RectumStage IV Colon CancerStage IV Rectal CancerNCT01814501John Hays16