Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cancer (S10PANI01)

Phase II Study to Investigate the Efficacy of Panitumumab in Platinum-resistant Advanced Head and Neck Squamous Cance

Phase II, multicenter, open labelled, uncontrolled study to evaluate the efficacy and safety profile of panitumumab in patients affected by Head and Neck cancer after at least one cisplatin or carboplatin-based chemotherapy. A translational research study is also planned to evaluate Estimated Glomerular Filtration Rate (EGFR) status by FISH, KRAS, B-RAF, HRAS, NRAS and PIK3CA mutation by DNA sequencing, PTEN protein expression by immunohistochemistry, and Human Papilloma Virus (HPV) genotyping by reverse hybridization.

Panitumumab is administered iv on days 1 and 15 of a 28 days cycle, until progressive disease, unacceptable toxicity, pregnancy, or patient's refusal

Study Overview

• Status: Completed
• Conditions: Advanced Head and Neck Squamous Cancer
• Intervention / Treatment: Drug: Panitumumab

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2, not pregnant.
• Histologically or cytologically confirmed Squamous Cell Cancer of the Head and Neck either metastatic or recurrent, judged incurable by surgery or radiation.
• Baseline tumor tissue, sufficient material available for EGFR determination (therapeutic target of panitumumab) and biomarker studies. Patients without available tissue at baseline or with tissue collected longer than 1 year before, may undergo tumor biopsy.
• Progression after or not responding to treatment with at least one cis-platin or carboplatin containing regimen.
• Measurable disease (Response Evaluation Criteria in Solid Tumours - RECIST 1.1).
• Adequate hematological values, renal and hepatic function.
• Patients may not be receiving any other investigational agents

Exclusion Criteria:

• Platinum-naïve patients.
• Patients previously progressed after a regimen containing EGFR-inhibiting agents (as cetuximab, panitumumab, gefitinib, erlotinib), even if there was an initial response.
• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) 1 year before enrollment/randomization.
• History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest computed tomography scan.
• Known or suspected brain metastases.
• Psychiatric disorder precluding understanding of information on trial related topics, giving informed consent
• Known hypersensitivity to panitumumab active ingredient or excipients.
• Any concomitant drugs contraindicated for use with the trial drug according to the Swissmedic approved product information - Human Immunodeficiency Virus (HIV) positive patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Panitumumab; 6 mg/kg per administration	Drug: Panitumumab; IV administration every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of tumor response in advanced platinum-resistant head and neck cancer	To evaluate rate of radiological tumor response in advanced platinum-resistant head and neck cancer	Radiological tumor evaluation every 8 weeks, minimum 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) v.3	To collect all adverse event occurred during the treatment	Collection of adverse event for at least the first 8 weeks
Analysis of tumor biomarkers	To identify the tumor biomarkers that can best predict response to panitumumab	28 days (1 cycle)

Collaborators and Investigators

• Sponsor: Southern Europe New Drug Organization
• Collaborators: Clinical Trial Unit Ente Ospedaliero Cantonale
• Investigators: Study Chair: Michele Ghielmini, Prof, Oncology Institute of Southern Switzerland

Publications and helpful links

General Publications

• Siano M, Molinari F, Martin V, Mach N, Fruh M, Freguia S, Corradino I, Ghielmini M, Frattini M, Espeli V. Multicenter Phase II Study of Panitumumab in Platinum Pretreated, Advanced Head and Neck Squamous Cell Cancer. Oncologist. 2017 Jul;22(7):782-e70. doi: 10.1634/theoncologist.2017-0069. Epub 2017 Jun 7.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: December 8, 2015
• First Submitted That Met QC Criteria: December 29, 2015
• First Posted (Estimate): December 30, 2015

Study Record Updates

• Last Update Posted (Actual): October 27, 2021
• Last Update Submitted That Met QC Criteria: October 19, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Panitumumab
• Other Study ID Numbers: S10PANI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO