Overview

This trial is active, not recruiting.

Conditions cancer, carcinoma, head and neck cancer, metastases, metastatic cancer, metastatic or recurrent squamous cell carcinoma of head and neck, oncology, squamous cell carcinoma, tumors
Treatment panitumumab
Phase phase 2
Target EGFR
Sponsor Amgen
Start date May 2007
End date February 2011
Trial size 52 participants
Trial identifier NCT00446446, 20062088

Summary

This is an open-label, single-arm, phase 2, multi-center, clinical trial of panitumumab monotherapy for second-line treatment of metastatic or recurrent squamous cell carcinoma of head and neck (SCCHN) subjects. This study will be conducted in North America. Approximately 50 subjects with histologically or cytologically confirmed metastatic and/or recurrent SCCHN will be enrolled into the trial.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single Arm Monotherapy Study
panitumumab
Single Arm Monotherapy Study

Primary Outcomes

Measure
To estimate the effect of second-line panitumumab monotherapy on objective response rate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck
time frame: 70 days

Secondary Outcomes

Measure
Duration of response
time frame: 70 days
Rate of disease control
time frame: 70 days
Exploratory
time frame: 70 days
Time to progression (TTP)
time frame: 70 days
Progression free survival (PFS)
time frame: 70 days
Overall survival (OS)
time frame: 70 days
Safety
time frame: 70 days
Time to response
time frame: 70 days

Eligibility Criteria

Male or female participants at least 18 years old.

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 CT or 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.

Additional Information

Official title Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Amgen.