EUCTR2007-005722-79-FR进行中（未招募）1 期
A Randomized, Open-Label, Controlled, Phase II Trial of Combination Chemotherapy with or without Panitumumab as First-line Treatment of Subjects with Metastatic or Recurrent Head and Neck Cancer, and Cross-over Second-line Panitumumab Monotherapy of Subjects who Fail the Combination Chemotherapy Only Arm.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Amgen Inc
- 入组人数
- 113
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
- •Inclusion Criteria
- •The following inclusion criteria must be met at the time of subject randomization.
- •Disease Related
- •Histologically or cytologically confirmed SCCHN or its variants (eg, basaloid
- •squamous cell carcinoma and adenosquamous cell carcinoma).
- •Primary tumor of the oropharynx, oral cavity, hypopharynx, or larynx, or
- •SCCHN of unknown primary.
- •Diagnosis of metastatic disease and/or recurrent disease determined to be
- •incurable by surgery or radiotherapy.
- •No prior systemic treatment for metastatic and/or recurrent SCCHN
- •Subjects who have received radiation as primary therapy are eligible if radiation
- •therapy treatment was completed > 4 weeks prior to randomization
- •Subjects who have previously received chemotherapy as part of the initial
- •multimodality treatment for locally advanced disease are eligible if the
- •chemotherapy was completed > 24 weeks prior to randomization
- •At least 1 unidimensionally measurable lesion of = 20 mm using conventional
- •techniques or =10 mm with spiral CT scan. Target lesions must not be chosen
- •from a previously irradiated field unless there had been documented tumor
- •progression in that lesion prior to randomization
- •Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1
- •at screening
- •Demographic
- •Men or women age = 18 years
- •Adequate hematologic data as follows (= 7 days before randomization):
- •- ANC = 1.5 x 109/L
- •- Platelet count = 100 x 109/L
- •- Hemoglobin = 9.0 g/dL
- •Adequate renal function (= 7 days before randomization):
- •- Adequate renal function with creatinine clearance = 50 mL/min calculated
- •by the Cockcroft-Gault method as follows:
- •- Male creatinine clearance = (140 - age) x (weight in kg) / (serum
- •- Female creatinine clearance = (140 - age) x (weight in kg) x 0.85 /
- •(serum Cr x 72)
- •Electrolyte function, as follows (= 7 days before randomization). If < lower limit of
- •normal (LLN), subject may receive appropriate treatment and may be
- •rescreened.
- •- Magnesium = LLN
- •- Calcium = LLN (If serum albumin is low, corrected calcium or ionized
- •calcium should be = LLN)
- •- Potassium = LLN
- •Adequate hepatic function as determined by (= 7 days before randomization):
- •- Aspartate aminotransferase (AST) = 1.5 x upper limit of normal (ULN)
- •- Alanine aminotransferase (ALT) = 1.5 x ULN
- •- Alkaline phosphatase (ALK-P) = 2.5 x ULN
- •- Total bilirubin = ULN, unless attributed to Gilbert’s syndrome
- •Negative urine or serum pregnancy test = 72 hours prior to randomization
- •(females of childbearing potential only)
- •Before any non-standard of care study-specific procedure, subjects or their
- •legally acceptable representative must be able to comprehend and have signed
- •and dated the applicable independent ethics committee (IEC) or institutional
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排除标准
- •Exclusion Criteria
- •Subjects who meet any of the following criteria at the time of randomization must be
- •excluded from participation in this study.
- •Disease Related
- •Documented or symptomatic central nervous system (CNS) metastases
- •Nasopharyngeal carcinoma
- •History of interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or
- •evidence of interstitial lung disease on baseline chest computerized tomography
- •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 = 3 years prior to
- •randomization
- •Clinically significant cardiovascular disease (including myocardial infarction,
- •unstable angina, symptomatic congestive heart failure, serious uncontrolled
- •cardiac arrhythmia) = 1 year of randomization
- •Subjects whose only site of metastatic disease is a single spiculated lung nodule
- •are assumed to have a second lung primary, and are excluded unless there is
- •unequivocal pathological confirmation of metastasis of the SCCHN primary
- •Pulmonary embolism, deep vein thrombosis, or other significant thromboembolic
- •event = 8 weeks prior to randomization
- •Symptomatic peripheral neuropathy of Grade = 2 based on the CTCAE v3.0
- •(Symptomatic weakness and/ or sensory alteration or paresthesia (tingling) that
- •is interfering with function but not interfering with Activities of Daily Living
- •Subjects not recovered from all previous acute radiotherapy-related toxicities to =
- •History of severe skin disorder that in the opinion of the investigator may interfere
- •with study conduct
- •Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C
- •virus, acute or chronic hepatitis B infection
- •Any co-morbid disease that would increase risk of toxicity
- •History of any medical, or psychiatric condition, or laboratory abnormality that in
- •the opinion of the investigator may increase the risks associated with the study
- •participation, or may interfere with the interpretation of the results
- •Active infection requiring systemic treatment or any uncontrolled infection = 14
- •days prior to randomization
- •Hearing loss of Grade = 3 based on the CTCAE v3.0 Auditory/Ear (Hearing loss
- •requiring hearing aid or intervention (ie, interfering with ADL [without monitoring
- •Medications and Treatments
- •Known allergy or hypersensitivity to panitumumab, or other study medications.
- •Prior anti-EGFr antibody therapy (eg, cetuximab) or treatment with small
- •molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) unless received as
- •part of prior multimodality treatment (eg, as a radiation sensitizer) and
- •completed > 24 weeks prior to randomization.
- •Subject is currently enrolled in or = 30 days since ending other investigational
- •device, investigational procedure, or drug study(s), or subject is receiving other
- •investigational agent(s)
- •Subjects requiring use of immunosuppressive agents (eg, methotrexate and
- •cyclosporine), however, corticosteroids are allowed
- •Man or woman of child-bearing potential (women who are post-menopausal < 52
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研究者
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