PARTNER: Panitumumab Added to Regimen for Treatment of Head aNd Neck Cancer Evaluation of Response

• Conditions: Cancer of the Head and Neck; MedDRA version: 16.1Level: PTClassification code 10060121Term: Squamous cell carcinoma of head and neckSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-005722-79-LT
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-09
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

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 and < 70 years

Laboratory

• 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 = 60 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)

• 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)

Ethical

• 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
review board (IRB) approved written Informed Consent Form (ICF).
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 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

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
(CT) scan

• 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
[ADL])

• Subjects not recovered from all previous acute radiotherapy-related toxicities to = grade 1

• 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 studyparticipation, 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
program])

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

General

• Man or woman of child-bearing potential (women who are post-menopausal < 52
weeks, not surgically sterilized, or not abstinent) who do not consent to use
adequate contraceptive precautions (per institutional standard of care) during the
course of the study, a

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified