Radiotherapy Plus Panitumumab Compared to Chemoradiotherapy With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- Conditions
- Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and NeckMedDRA version: 14.0 Level: LLT Classification code 10060121 Term: Squamous cell carcinoma of head and neck System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2007-001438-15-GB
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 150
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 127
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
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
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 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
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