Status:
COMPLETED
PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
Lead Sponsor:
Amgen
Conditions:
Cancer
Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2017
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00446446
Start Date
October 30 2007
End Date
November 29 2017
Last Update
October 5 2022
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