PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

• Status: Completed
• Trial end date: 2017-11-29
• Target enrollment: 0
• Participant gender: All

Summary

To estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Antibodies, Monoclonal; Panitumumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using computed tomography (CT) or magnetic resonance imaging (MRI) scan

• Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy

• Karnofsky Performance Status (KPS) score ≥ 60% at screening

• Men or women age ≥18 years

• Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test

Exclusion Criteria:

• Subject received > 1 chemotherapy regimen for the treatment of metastatic or recurrent disease

• Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen

• Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases

• History of interstitial lung disease, significant cardiovascular disease, or another primary cancer

• Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection

• Known allergy or hypersensitivity to any component of panitumumab

• Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions:

• Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed > 24 weeks prior to randomization

• Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.

• Significant thromboembolic event ≤ 8 weeks prior to enrollment

• Subjects not recovered from all previous acute radiotherapy-related toxicities

• History of severe skin disorder that in the opinion of the investigator may interfere with study conduct

• History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results

• Subject is currently in a clinical trial ≤ 30 days prior to enrollment

• Subjects requiring use of immunosuppressive agents however corticosteroids are allowed

• Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study

• Female subject who is pregnant or breast-feeding

• Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.