EUCTR2007-001438-15-CZ进行中（未招募）不适用
A Phase 2 Randomized Trial of Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy in Subjects with Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Amgen Inc.0 个研究点目标入组 150 人开始时间: 2007年7月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Disease-Related:
- •Histologically or cytologically confirmed SCC of oral cavity, oropharynx,
- •hypopharynx, or larynx
- •Stage III or Stage IVa-b (M0) disease according to the American Joint Committee
- •on Cancer staging manual 6th edition
- •ECOG performance status of 0 or 1 (refer to Appendix H)
- •Bidimensionally measurable disease = 10 mm in at least 1 dimension
- •Demographic:
- •Man or woman = 18 years of age
- •Laboratory:
- •Hematological function, as follows (= 10 days prior to randomization):
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Platelet count = 100 x 109/L
- •Hemoglobin = 9 g/dL
- •Renal function, as follows (=10 days prior to randomization):
- •Creatinine clearance = 50 mL/min as calculated from 24 hour urine collection (required for subjects with serum Cr > ULN) or calculated from the Cockcroft - Gault formula as follows:
- •Male creatinine clearance = (140 - age) x (weight in kg) / (serum Cr x 72)
- •Female creatinine clearance = (140 - age) x (weight in kg) x 0.85/(serum Cr x 72)
- •Hepatic function, as follows (=10 days prior to randomization):
- •Aspartate aminotransferase (AST) = 2 x ULN
- •Alanine aminotransferase (ALT) = 2 x ULN
- •Total bilirubin = 2 x ULN
- •Metabolic function, as follows (=10 days prior to randomization):
- •Serum magnesium = LLN
- •Negative pregnancy test = 72 hours prior to randomization (females of
- •child bearing potential)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Disease Related:
- •Primary tumor of the nasopharynx, sinuses, salivary gland, or skin
- •Subjects requiring prophylactic tracheostomy
- •Prior (or concomitant) malignancy (except non-melanomatous skin cancer or in situ
- •cervical cancer), other than the study disease (SCCHN), unless treated with curative intent with no evidence of disease for = 3 years
- •Medications or Radiotherapy:
- •Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small molecule
- •tyrosine kinase inhibitors of EGFr (eg, gefitinib, erlotinib, lapatinib)
- •Prior surgery for SCCHN (except nodal sampling or biopsy for study disease)
- •Prior radiotherapy in the planned field
- •Prior systemic chemotherapy for the study cancer
- •Major surgery = 28 days before randomization or minor surgery = 14 days before
- •randomization with the exception that feeding tube placement, dental extractions,
- •central venous catheter placement, biopsies (endoscopic or otherwise), and nodal
- •sampling are allowed at any time prior to randomization
- •Known allergy or hypersensitivity to any component of the study drugs
- •Clinically significant cardiovascular disease (including myocardial infarction,
- •unstable angina, symptomatic congestive heart failure, serious uncontrolled
- •cardiac arrhythmia) = 1 year prior to randomization
- •Chronic obstructive pulmonary disease resulting in hospitalization due to
- •pneumonia or respiratory decompensation = 6 months prior to screening
- •History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
- •evidence of interstitial lung disease on screening chest CT scan
- •Active infection requiring systemic treatment or any uncontrolled infection =
- •14 days prior to randomization
- •Any uncontrolled condition, which, in the opinion of the investigator, would interfere
- •in the safe and timely delivery of study treatment
- •Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C
- •virus, chronic active hepatitis B infection or any co-morbid disease that would increase the risk of toxicity
- •Pregnant or breast-feeding women
- •Men not willing to use adequate contraception precautions for the duration of the
- •study and for 1 month following the last administration of study treatment
- •Women of childbearing potential not using adequate contraception precautions for
- •the duration of the study and for 6 months following the last administration of study
- •Subject unwilling or unable to comply with study requirements
- •Participation in other investigational device or drug studies within 30 days before
- •randomization
- •Previously randomized into this study
- •Any kind of disorder that compromises the ability of the subject to give written
- •informed consent and/or to comply with study procedures
研究者
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