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 - ND

Conditions: Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck
MedDRA version: 6.1Level: HLTClassification code 10024530

Registration Number: EUCTR2006-003786-13-IT

Lead Sponsor: AMGEN S.P.A.

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 >= 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 >= 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 >= 18 years of age 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 (CrCl) >= 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 (<= 10 days prior to randomization): − Aspartate aminotransferase (AST) <= 3 x upper limit of normal (ULN) (<= 5 X ULN if liver metastases) − Alanine aminotransferase (ALT) <= 3 x ULN (<= 5 X ULN if liver metastases) − Total bilirubin <= 1.5 X ULN Electrolytes, as follows (<= 10 days prior to randomization): − Magnesium >= lower limit of normal (LLN) Negative pregnancy test <= 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 >= 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 < 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, cetuximab) 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) <= 28 days or minor surgery (excluding central venous catheter placement, percutaneous feeding tube, and biopsy) <= 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) <= 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 >= 2 based on the CTCAE v3.0 Grade >= 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 <= 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 <= 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 barrier contraceptive methods (eg, diaphragm plus condom) during the course of the study and for 6 months after the last investigational prod

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess whether panitumumab plus chemotherapy improves overall survival (OS) compared to chemotherapy alone as first line treatment for metastatic and/or recurrent squamous cell carcinoma of the head and neck (SCCHN).;Secondary Objective: To evaluate progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), time to progression (TTP), and safety.;Primary end point(s): Efficacy: OS

Secondary Outcome Measures

Name	Time	Method

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