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Trial registered on ANZCTR


Registration number
ACTRN12619001051134
Ethics application status
Approved
Date submitted
24/06/2019
Date registered
26/07/2019
Date last updated
26/07/2019
Date data sharing statement initially provided
26/07/2019
Date results information initially provided
26/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Testing whether prochlorperazine can be safely used to move anti-cancer therapy targets temporarily to tumour cell surfaces.
Scientific title
A pilot study of an old drug with a new use – prochlorperazine to improve anti-EGFR therapy in squamous cell carcinoma of the mucosa
Secondary ID [1] 298567 0
None
Universal Trial Number (UTN)
Trial acronym
None
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma 313403 0
Condition category
Condition code
Cancer 311836 311836 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prochlorperazine 0.8mg/kg by intravenous infusion over 20-30 mins; tissue biopsy from tumour areas accessible without surgery occurred prior to start of infusion and 60-90 minutes post-infusion.
Intervention code [1] 314822 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320510 0
Objective primary outcome: Change in available cetuximab binding sites on patient tumour as measure by EGF-Alexa 488 uptake in live ex-vivo biopsy as per assay published Joseph et al 2019 Journal of Investigative Dermatology DOI: doi:10.1016/j.jid.2018.06.190
Timepoint [1] 320510 0
Live ex-vivo tumours were assessed for EGF uptake within 30 minutes of removal from patient. Tumours were fixed overnight and processed the following day before confocal analysis was undertaken as described in Joseph et al 2019 10.1016/j.jid.2018.06.190. Thus assessment was usually completed within 3 days of biopsy.
Primary outcome [2] 320806 0
Safety: The Investigator and designated research nurse will monitor each Participant for adverse events during the study. The Investigator or designee will ask the Participant non-leading questions in an effort to detect adverse events. The investigator will exercise his or her medical and scientific judgement in deciding whether an abnormal laboratory finding or other abnormal assessment is clinically significant.Abnormal assessments (e.g. ECG, vital signs) that are judged by the investigator as clinically significant will be recorded as AEs or SAEs. Adverse events will be assessed for intensity, causality and expectedness. All AEs and SAEs will be followed until resolution, until the condition stabilises, until the event is otherwise explained.
Timepoint [2] 320806 0
From initial i.v. infusion, up to 1 week.
Secondary outcome [1] 371850 0
Nil
Timepoint [1] 371850 0
Nil

Eligibility
Key inclusion criteria
Histologically confirmed squamous cell carcinoma of head and neck mucosa
Tumour of any stage amenable to biopsy
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Eastern Cooperative Oncology Group (ECOG) performance status equal to or greater than 2; On drugs that cause long QTc ; History of prolonged QT interval or prolonged QT interval on baseline ECG; Systolic blood pressure less than 90mmHg and/or diastolic blood pressure < 50 mmHg in two consecutive blood pressure readings within the 1 hour prior to study drug administration; Previous reaction to antipsychotic medications requiring medical intervention; Pregnant or breast feeding
Excluded if Parkinson’s disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14058 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 26849 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 303106 0
University
Name [1] 303106 0
The University of Queensland
Address [1] 303106 0
Level 7, General Purpose South Building (Building 78)
Staff House Road
The University of Queensland
Brisbane, Queensland 4072
Country [1] 303106 0
Australia
Primary sponsor type
University
Name
University Of Queensland
Address
Level 7, General Purpose South Building (Building 78)
Staff House Road
The University of Queensland
Brisbane, Queensland 4072
Country
Australia
Secondary sponsor category [1] 303118 0
None
Name [1] 303118 0
n/a
Address [1] 303118 0
n/a
Country [1] 303118 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303651 0
Metro South Hospital and Health Service HREC
Ethics committee address [1] 303651 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 303651 0
Australia
Date submitted for ethics approval [1] 303651 0
16/01/2015
Approval date [1] 303651 0
12/03/2015
Ethics approval number [1] 303651 0

Summary
Brief summary
The purpose of this study is to test if a chemical called prochlorperazine (Stemetil) can move the target of a chemotherapy drug called cetuximab to the surface of cancer cells.

Who is it for?
You may be eligible for this study of you are aged 18 or over and have a squamous cell carcinoma of head and neck which is amenable to biopsy

Study details
All participants in this study will have a small biopsy of their tumour then an infusion of the study drug (prochlorperazine) through a needle in their arm 60-90 minutes before another biopsy of their tumour. The biopsy sample will be analysed in a laboratory to see the effect of the drug on a receptor on the surface of cancer cells.

It is hoped this research will demonstrate that prochlorperazine makes cancer cells more sensitive to the chemotherapy drug cetuximab.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94402 0
Prof Ben Panizza
Address 94402 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 94402 0
Australia
Phone 94402 0
+61 7 31763219
Fax 94402 0
Email 94402 0
ben.panizza@health.qld.gov.au
Contact person for public queries
Name 94403 0
Ms Melissa Brauer
Address 94403 0
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country 94403 0
Australia
Phone 94403 0
+61 731763219
Fax 94403 0
Email 94403 0
melissa.brauer@health.qld.gov.au
Contact person for scientific queries
Name 94404 0
Dr Fiona Simpson
Address 94404 0
Translational Research Institute
University of Queensland
37 Kent St
Woolloongabba
QLD 4102
Country 94404 0
Australia
Phone 94404 0
+61 422721656
Fax 94404 0
Email 94404 0
f.simpson@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
In summary it was found that EGFR can be re-localised to the surface of tumours temporarily and reversibly in patients and the study moved forward to a Phase IB dose escalation study.