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

NCT02643056 | Completed Phase 2

• 1 other identifier: S10PANI01
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Advanced Head and Neck Squamous Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) v.3

  Collection of adverse event for at least the first 8 weeks

• Analysis of tumor biomarkers

  28 days (1 cycle)

Study Arms (1)

Panitumumab

EXPERIMENTAL

6 mg/kg per administration

Drug: Panitumumab

Interventions

Panitumumab DRUG

IV administration every 2 weeks

Panitumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Southern Europe New Drug Organization: lead
• Clinical Trial Unit Ente Ospedaliero Cantonale: collaborator

Related Publications (1)

• 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.

  PMID: 28592616 DERIVED

MeSH Terms

Interventions

Panitumumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michele Ghielmini, Prof

  Oncology Institute of Southern Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project Manager

Study Record Dates

• First Submitted: December 8, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share