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

NCT ID: NCT02643056

Last Updated: 2021-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Advanced Head and Neck Squamous Cancer

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

6 mg/kg per administration

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

IV administration every 2 weeks

Interventions

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Panitumumab

IV administration every 2 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Trial Unit Ente Ospedaliero Cantonale

OTHER

Sponsor Role collaborator

Southern Europe New Drug Organization

OTHER

Sponsor Role lead

Responsible Party

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Tatiana Terrot

Project Manager

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michele Ghielmini, Prof

Role: STUDY_CHAIR

Oncology Institute of Southern Switzerland

References

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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.

Reference Type DERIVED
PMID: 28592616 (View on PubMed)

Other Identifiers

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S10PANI01

Identifier Type: -

Identifier Source: org_study_id