A Phase 2, Randomized Trial of Chemoradiation with or withoutPanitumumab in Subjects with Unresected, Locally Advanced Squamous CellCarcinoma of the Head and Neck

Conditions: Advance Squamous Cell Carcinoma of the Head and Neck
MedDRA version: 9.1Level: LLTClassification code 10060121Term: Squamous cell carcinoma of head and neck

Registration Number: EUCTR2007-001439-74-DE

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 246

Inclusion Criteria

Disease-Related:
•Histologically or cytologically confirmed SCC of oral cavity, oropharynx, hypopharynx, or larynx.
•Subjects requiring prophylactic tracheostomy.
•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

Exclusion Criteria

Disease Related:
•Primary tumor of the nasopharynx, sinuses, salivary gland, or skin.
•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.

General:
•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 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 treatment.
•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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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