Clinical trial · Interventional

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

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

NCT02643056CI-TRIAL-00054696S10PANI01completedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Advanced Head and Neck Squamous Cancer	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Panitumumab	Drug	Panitumumab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Panitumumab
description
6 mg/kg per administration
interventionNames
1. Drug: Panitumumab

Primary outcomes (1)

measure
Rate of tumor response in advanced platinum-resistant head and neck cancer
timeFrame
Radiological tumor evaluation every 8 weeks, minimum 12 weeks
description
To evaluate rate of radiological tumor response in advanced platinum-resistant head and neck cancer

Secondary outcomes (2)

measure
Adverse Event according to Common Terminology Criteria for Adverse Events (CTCAE) v.3
timeFrame
Collection of adverse event for at least the first 8 weeks

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (1)

DERIVEDSiano 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