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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-30

Study Completion Date

2017-11-29

Brief Summary

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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).

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Detailed Description

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Conditions

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Cancer Carcinoma Head and Neck Cancer Metastases Metastatic Cancer Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck Oncology Squamous Cell Carcinoma Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Panitumumab

articipants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.

Interventions

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Panitumumab

Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.

Intervention Type DRUG

Other Intervention Names

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Vectibix

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No