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Trial registered on ANZCTR
Registration number
ACTRN12624000917538
Ethics application status
Approved
Date submitted
26/06/2024
Date registered
29/07/2024
Date last updated
29/07/2024
Date data sharing statement initially provided
29/07/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Efficacy and safety of cetuximab and prochlorperazine combined for solid organ transplant patients with advanced Cutaneous Squamous Cell Carcinoma: CetPro study
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Scientific title
Efficacy and safety of cetuximab and prochlorperazine combined for solid organ transplant patients with advanced Cutaneous Squamous Cell Carcinoma: CetPro study
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Secondary ID [1]
312412
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none
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Universal Trial Number (UTN)
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Trial acronym
CetPro
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
skin cancer
334223
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solid organ transplant recipients
334224
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Condition category
Condition code
Cancer
330893
330893
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0
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Non melanoma skin cancer
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Surgery
331020
331020
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Efficacy and safety of cetuximab and prochlorperazine combined
Day 1: Cetuximab will be administered at 500mg/mg2 via intravenous infusion.
Day 8: Cetuximab will be administered at 250mg/mg2 via intravenous infusion. Prochlorperazine will then be administered at a dose of 0.8mg/kg via intravenous infusion 1 hour after the completion of cetuximab. Cetuximab and prochlorperazine (0.8mg/kg) will be administered in combination on a weekly basis for a total of 6 weeks (Day 8, Day 15, Day 22, Day 29, D36, D43) (total treatment period of 7 weeks).
Depending on the response this treatment can be reconducted for a new period of 6 weeks.
All patient assessment/monitoring is recorded in the patient clinical record including observations, medication charts and clinical notes.
If necessary, depending on clinician decision, antihistamines and corticosteroids will be administered 30 min before cetuximab administration: Oral Loratadine 10mg and
Intravenous hydrocortisone 100mg.
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Intervention code [1]
328914
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Treatment: Drugs
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Intervention code [2]
328915
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
338648
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To determine the disease control rate (DCR) as a measure of efficacy.
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Assessment method [1]
338648
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as assessed by the investigator using RECIST 1.1 criteria DCR is defined as the percentage of patients whose disease either shrinks or remains stable over a specific time period.
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Timepoint [1]
338648
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at 6- and 12-weeks post-commencement of combination treatment (Cetuximab + PCZ).
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Secondary outcome [1]
436835
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To determine the clinical efficacy assessed via tumour size
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Assessment method [1]
436835
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The clinician will measure clinical effectiveness using a measuring ruler and his hand, by measuring the length, width, and height of the tumor on the patient's skin. This measurement is performed clinically.
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Timepoint [1]
436835
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at 6- and 12-weeks post-commencement of combination treatment (Cetuximab+PCZ).
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Secondary outcome [2]
436836
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Overall survival advantage with the addition of prochlorperazine to cetuximab
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Assessment method [2]
436836
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Data is collected from patient medical records. The length of time from either the date of diagnosis or the start of treatment such as cancer, that patients diagnosed with the disease are still alive.
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Timepoint [2]
436836
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The study is completed when the last patient has been followed for a minimum of 18 weeks or until death.
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Secondary outcome [3]
437422
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To determine the Objective Response Rate (ORR) as a measure of efficacy
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Assessment method [3]
437422
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as assessed by the investigator using RECIST 1.1. ORR is defined as the percentage of patients who achieve a response, which can either be complete response (CR: complete disappearance of lesions) or partial response (PR: reduction in the sum of maximal tumor diameters by at least 30% or more).
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Timepoint [3]
437422
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at 6 and 12 weeks for the combination treatment (Cetuximab+PCZ).
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Secondary outcome [4]
437423
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To determine the progression free survival (PFS) advantage with the addition of prochlorperazine to cetuximab
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Assessment method [4]
437423
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Data is collected from patient medical records.
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Timepoint [4]
437423
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The study is completed when the last patient has been followed for a minimum of 18 weeks or until death.
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Secondary outcome [5]
437424
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To establish the safety of administering cetuximab in combination with prochlorperazine.
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Assessment method [5]
437424
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This is by documenting toxicity using CTCAE V5.0 and recording additional adverse events. Safety is defined as 80% of patients receiving cetuximab and prochlorperazine without any Grade IV toxicity (= life-threatening consequences or urgent intervention indicated).
Data is collected from patient medical records.
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Timepoint [5]
437424
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The study is completed when the last patient has been followed for a minimum of 18 weeks or until death.
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Secondary outcome [6]
437425
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To analyse the Epidermal Growth Factor Receptor (EGFR) and its uptake pre- and post-treatment.
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Assessment method [6]
437425
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Translational analysis on skin samples
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Timepoint [6]
437425
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Pre-screening biopsy before commencement of combination treatment (Cetuximab+PCZ)., and biopsy at Day8
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Secondary outcome [7]
437426
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To characterize at a subcellular level advanced cSCC in SOTRs with long-read DNA sequencing.
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Assessment method [7]
437426
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Long-read DNA sequencing on skin biopsy
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Timepoint [7]
437426
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Before commencement of combination treatment (Cetuximab+PCZ).
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Secondary outcome [8]
437427
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Number of patients becoming eligible for surgery
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Assessment method [8]
437427
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Data is collected from patient medical records.
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Timepoint [8]
437427
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at 6- and 12-weeks post-commencement of combination treatment (Cetuximab + PCZ).
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Eligibility
Key inclusion criteria
1. Radiological and/or histologically confirmed advanced cutaneous SCC
2. EGFR staining positively on tumour biopsy.
3. At screening, non-suitable for or refusing surgery, radiotherapy or immunotherapy
4. Accessible tumour for biopsy.
5. Solid organ transplant recipient of more than 1 year.
6. Life expectancy of greater than three months.
7. Male or female, at least 18 years of age or more.
8. ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
9. Can provide informed consent and are willing to participate for the duration of the study and to follow study procedures.
10. Able to commit to a 4-hour clinic visit and to abstaining from driving and operating machinery for a 24-hour period.
11. Female patients of childbearing potential will be required to have a negative pregnancy test prior to enrolment and be required to practice an effective form of contraception. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test at enrolment prior to each treatment cycle and use a highly effective contraceptive method including the oral contraceptive pill (OCP) or an intrauterine hormone device (IUD) commencing at screening and until at least 1 month following the last dose of Cetuximab. Females who are abstinent from heterosexual intercourse as part of their usual lifestyle do not need to use contraception.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Treatment with any investigational agent within the preceding 4 weeks from date of consent, or within 5 half-lives of the investigational agent, whichever is longer.
2. Unknown EGFR status and no lesion accessible for biopsy.
3. Known hypersensitivity to EGFR inhibitors.
4. Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) less than one year before enrolment.
5. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease previous imaging.
6. ECOG performance status more than 2
7. Taking medications with a known risk of prolonging QTc interval
8. History of prolonged QT interval or prolonged QT interval on baseline screening electrocardiogram (ECG) (standard 12-lead (ECG) parameters after 5 minutes resting in supine position with PR longer than 120 milliseconds (ms) and less than 220 ms, QRS less than 120 ms, QTcF egal to 450 ms for males and egal to 470 ms for females, and otherwise normal ECG.)
9. Systolic blood pressure less than 90mmHg and/or diastolic blood pressure less than 50 mmHg in two consecutive blood pressure readings within the hour prior to study drug administration.
10. Previous reaction to antipsychotic medications, antihistamines, and steroids.
11. Parkinson’s disease or other chronic extrapyramidal conditions.
12. Subject is pregnant or breast feeding or planning to become pregnant within 6 months after the end of treatment.
13. Subject (male or female) of childbearing age not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
14. High risk for poor compliance.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
10 patients from the Transplant Skin Clinics or the Queensland Head and Neck Cancer Centre or Cancer Services Oncology within the Princess Alexandra Hospital will be recruited.
We have scheduled an interim analysis after enrolling five patients for evaluation.
Safety analyses will include all participants who received at least one dose of study treatment.
Efficacy analyses will be by intention-to-treat and include all participants recruited who received at least one dose,
Time to event data will be summarised using the Kaplan Meier method including all participants
recruited.
Measures of effect will be reported with 2-sided 95% confidence intervals calculated with
appropriate methods.
Full Analysis Set: Suitable regression models will be used to test the effects of baseline characteristics on key endpoints, e.g. location, type of transplant, pathological characteristics... Logistic regression will be used for dichotomous endpoints. Cox proportional hazards models will be used for time-to-event
endpoints. Sensitivity analyses will be used to assess effects on the findings and conclusions of excluding
participants who were deemed ineligible, unevaluable, or did not receive study treatment.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
28/11/2025
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Actual
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Date of last data collection
Anticipated
17/07/2026
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Actual
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Sample size
Target
10
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
26733
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
42780
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4102 - Woolloongabba
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Funding & Sponsors
Funding source category [1]
316823
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Government body
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Name [1]
316823
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Metro South Health Research Support Scheme (MSH RSS)
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Address [1]
316823
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Country [1]
316823
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Australia
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Primary sponsor type
University
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Name
The University of Queensland
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Address
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Country
Australia
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Secondary sponsor category [1]
319052
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None
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Name [1]
319052
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Address [1]
319052
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Country [1]
319052
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315593
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Metro South Human Research Ethics Committee
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Ethics committee address [1]
315593
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https://metrosouth.health.qld.gov.au/research/about-us/hrec
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Ethics committee country [1]
315593
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Australia
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Date submitted for ethics approval [1]
315593
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16/03/2023
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Approval date [1]
315593
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26/02/2024
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Ethics approval number [1]
315593
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94554
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Summary
Brief summary
This study aims to evaluate the effectiveness and safety of combining prochlorperazine (PCZ) (Stemetil®) with cetuximab, an anti-EGFR (Epidermal Growth Factor Receptor) antibody used in cutaneous squamous cell carcinoma (cSCC) treatment. Who is it for? You may be eligible for this study if you are a male or female age 18 or older. Additionally, you are a solid organ transplant recipient (such as kidney, liver, lung, or heart recipients) with non-operable or locally advanced or metastatic cutaneous squamous cell carcinoma (cSCCC) who are not suitable for surgery, radiotherapy alone, or immune checkpoint inhibitors. Study details All participants will be premedicated with antihistamines and corticosteroids before receiving an intravenous infusion of 0.8mg/kg of prochlorperazine with cetuximab once per week for 6 weeks, extendable depending on tolerance and response. As each study follow up, participant's medical record will be reviewed for disease progression, toxicity and survival. It is hoped that the findings from this study will open a new therapeutic strategy for advanced cSCCs in Solid Organ Transplant Recipients without compromising their allograft.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Kiarash Khosrotehrani
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Address
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Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba QLD 4102
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Country
135178
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Australia
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Phone
135178
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+61 7 3443 7399
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Fax
135178
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Email
135178
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[email protected]
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Contact person for public queries
Name
135179
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Dr Dousset Lea
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Address
135179
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Frazer Institute, The University of Queensland, 37 Kent Street, Woolloongabba QLD 4102
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Country
135179
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Australia
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Phone
135179
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+61734437088
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Fax
135179
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Email
135179
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[email protected]
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Contact person for scientific queries
Name
135180
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Dr Dousset Lea
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Address
135180
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Frazer Institute, The University of Queensland, 37 Kent Street, Woolloongabba QLD 4102
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Country
135180
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Australia
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Phone
135180
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+61734437088
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Fax
135180
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Email
135180
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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