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

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

Registration Number: EUCTR2006-003786-13-HU

Lead Sponsor: Amgen Inc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 650

Inclusion Criteria

• Histologically or cytologically confirmed SCCHN or its variants (eg, basaloid squamous cell carcinoma and adenosquamous cell carcinoma) of the oral cavity, oropharynx, hypopharynx, or larynx
• 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 (greater than or equal to) 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 (greater than or equal to) 3 months after the completion of radiation therapy.
• Measurable or non-measurable disease. Target lesions must not be chosen from a
previously irradiated field unless there has been radiographically and/or pathologically documented tumor progression in that lesion prior to randomization.
• ECOG performance status of 0 or 1
• Man or woman (greater than or equal to) 18 years of age
• Hematological function, as follows ((less than or equal to) 10 days prior to randomization):
• Absolute neutrophil count (ANC) (greater than or equal to) 1.5 x 109/L
• Platelet count (greater than or equal to) 100 x 109/L
• Hemoglobin (greater than or equal to) 9 g/dL
• Renal function, as follows ((less than or equal to) 10 days prior to randomization):
• Creatinine clearance (CrCl) (greater than or equal to) 50 mL/min calculated by the Cockcroft-Gault method 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 ((less than or equal to) 10 days prior to randomization):
• Aspartate aminotransferase (AST) (less than or equal to) 3 x upper limit of normal (ULN) ((less than or equal to) 5 X ULN if liver metastases)
• Alanine aminotransferase (ALT) (less than or equal to) 3 x ULN ((less than or equal to) 5 X ULN if liver metastases)
• Total bilirubin (less than or equal to) 1.5 X ULN
• Electrolytes, as follows ((less than or equal to) 10 days prior to randomization):
• Magnesium (greater than or equal to) lower limit of normal (LLN)
• Negative pregnancy test (less than or equal to) 72 hours prior to randomization (females of child bearing potential only)
• Before any study-specific procedure, the appropriate written informed consent must be obtained (see Section 12.1).
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

• Documented or symptomatic central nervous system 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 (greater than or equal to) 2 years prior to 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
• Nasopharyngeal carcinoma
• Prior systemic treatment for metastatic and/or recurrent SCCHN
• Subjects with recurrent disease may have received re-irradiation; however
subjects who received chemotherapy concomitantly with re-irradiation are excluded.
• Prior systemic chemotherapy for SCCHN as part of the initial multimodality treatment for locally advanced disease if completed (less than) 6 months prior to randomization
• Prior cisplatin-containing induction chemotherapy followed by cisplatin-containing
chemoradiotherapy
• Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, etuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib)
• Subjects requiring immunosuppressive agents (eg, methotrexate and cyclosporine),
however corticosteroids are allowed
• Known allergy or hypersensitivity to any component of the study drugs
• Major surgery requiring general anesthesia and a significant incision (ie, larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) (less than or equal to) 28 days or minor surgery (excluding central venous catheter placement, percutaneous feeding tube, and biopsy) (less than or equal to) 14 days prior to randomization. Subjects must have recovered from surgery related toxicities.
• 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 (greater than or equal to) 2 based on the CTCAE v3.0
• Grade (greater than or equal to) 3 hearing loss based on the CTCAE v3.0 Auditory/Ear (Hearing [without monitoring program])
• Subjects not recovered from all previous acute radiotherapy-related toxicities.
• Active infection requiring systemic treatment or any uncontrolled infection (less than or equal to) 14 days prior to randomization
• Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, chronic hepatitis B infection (testing is not required in the absence of clinical suspicion)
• Any co-morbid condition that would increase risk of toxicity (eg, suspected or confirmed dihydropyrimidine deficiency)
• Other investigational procedures are excluded
• Subject currently is enrolled in or (less than or equal to) 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s)
• Subject who is pregnant or breast feeding
• Man or woman of child-bearing potential not consenting to use adequate contraceptive precautions ie, double barr

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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