Carcinoma, Squamous CellPhase 2PASCENCT01129154
Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)
A Phase 2 study testing infusions of Panitumumab in people with Carcinoma, Squamous Cell, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
Trial summary
Squamous Cell Carcinoma (SCC) is one of the most common malignancies in caucasian population. The effect of the immune system on the development of skin tumors has been demonstrated in transplant patients taking immunosuppressive agents (65 fold risk increase). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Squamous Cell
- What is being tested?
- infusions of Panitumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesBelgium
- Study dates
- Aug 2010to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with histologically confirmed diagnosis of SCC.
- Patient must not be candidate to direct curative surgery.
- Tumor evaluation by photography with a ruler and CT-scan, MRI or PET-scan must be performed before enrollment.
- Age ≥ 18 years.
- Karnofsky Performance status (KPS) ≥70.
- Normal laboratory values:
Show all 16Show fewer
- Platelet count ≥100x103/μL
- Leucocyte count ≥ 3x103/μL
- Hemoglobin ≥ 9 g/dL
- ASAT and ALAT ≤ 2.5xUNL
- Serum creatinine ≤1.5xUNL
- Total bilirubin ≤ 1.5xUNL
- Magnesium ≥ Lower Normal Limit (LLN)
- Calcium ≥ Lower Normal Limit (LLN)
- Patient should agree to perform biopsies and blood collections for translational research.
- Signed informed consent from the patient or legal representative must be obtained.
Who cannot join
- Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure)in the past 12 months before enrollment.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- No prior chemotherapy.
- Prior anti-EGFR therapy.
- Radiation within four weeks prior to trial entry.
- Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
- Subject (male or female) not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months after the end of treatment.
- The patient has (or has had) previous or concomitant malignancies at other sites within last 5years, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites, 3 recruiting
- Recruiting
Cliniques Universitaires Saint-Luc Université Catholique de Louvain
Brussels, Brussels Capital, 1200
Baurain Jean-Francois, Md,PhD, +32 2 7645427, jean-françois.baurain@uclouvain.be
Duquenne Aline, MSc, +32 2 764 5427, aline.duquenne@uclouvain.be
- Recruiting
Cliniques Universitaires UCL
Mont Godinne, 5530
Kerger Joseph, MD, PhD, +32 81423328
- Recruiting
Cliniques Saint-Pierre
Ottignies, 1340
Duck Lionel, MD, +32 10414953
About this study
Official title: An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)
Squamous Cell Carcinoma (SCC) is one of the most common malignancies in caucasian population. The effect of the immune system on the development of skin tumors has been demonstrated in transplant patients taking immunosuppressive agents (65 fold risk increase). It has been reported that activation of EGFR and RAS signaling pathways play an important role in disease progression maybe through downregulation of the immune system.
The investigators want to treat unresectable SCC patients with an antibody against EGFR (Vectibix®, panitumumab). This antibody induces tumor regression in metastatic colorectal cancer and has been approved as single agent for this indication.
The investigators want to measure the response rate but also analyze the modification of expression profile of some key proteins involved or supposed to be involved in the signaling pathways of EGFR and in the regulation of the immune system. Chemokines such as CCL27 have been shown to play a critical role in the skin-associated immune response by regulating T cell homing. Pivarcsi et al have reported that downregulation of CCL27 is mediated by activation of EGFR/RAS/MAPK signaling pathways.
Read the detailed description
This is an open-label, multicentric study of 17 patients with skin squamous cancer cell.
Eligible patients should not be suitable for immediate surgery. If they have only one tumor, it should be greater than 3 cm2 in order to allow multiple biopsies.
Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
Patients will be assessed at baseline, at week 6 and then every 12 weeks till progression. In addition to clinical examination, evaluation tools will include photography and CT-scan, MRI or PET-scan.
Skin and tumor biopsies will be performed during first cycle at baseline and at days 2, 4, 8, 43, 85. Blood collections for translational research will be done during first cycle at baseline and at days 2, 4, 8,15, 43, 85. Blood collection for hematology and chemistry assessment will be done each 4weeks.
Patients presenting with a stable disease or a tumor response at week 12 will be eligible for maintenance cycles consisting in an infusion of panitumumab every 2 weeks till progression.
- Conditions
- Carcinoma, Squamous Cell
- Being tested
- infusions of Panitumumab
- Keywords
- Squamous cell carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
infusions of PanitumumabDrug
Also called Vectibix®
Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
| Study group | Role | What they receive |
|---|---|---|
| panitumumab | Experimental | Patients will receive six infusions of panitumumab every 2 weeks for the first cycle. Receives: Drug: infusions of Panitumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
To measure the efficacy of Panitumumab for SCC in terms of Overall Response Rate (ORR). Overall Response Rate (ORR) is defined as the sum of complete and partial tumour responses seen, divided by the total number of evaluable patients.
Measured: via imaging every 12 weeks
Secondary outcomes (4)
To assess the safety profile of panitumumab in SCC
Proportion of all adverse events will be reported. CTC scale 3.0 will be used with the exception of skin- or nail-related toxicities, which must be graded using CTC version 3.0 with modifications (Appendix E). Patients will be followed for safety until closure of study.
Measured: at each visit
Time to treatment failure (TTF)and Time to treatment progression TTP
Time to treatment failure (TTF) is defined as the time from date of first dose of study medication to first occurrence of any following event : documentation of objective tumor progression, toxicities requiring prematurely stop of treatment or death. TTF will be calculated according to the Kaplan-Meier technique. Time to Progression will also be calculated. Subjects without evidence of progression at the end of follow up will be considered as censored.
Measured: via imaging, every 12 weeks
To measure the duration of response.
Duration of overall response will be measured according RECIST guidelines version 1.1 Duration of response is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded on study).
Measured: via imaging, every 12 weeks
To explore the gene expression profiles in SCC under panitumumab treatment (i.e CCL27, EGFR,…).
Results will be presented as proportion of each expression type.
Measured: Skin and tumor biopsies will be performed at baseline and at days 2, 4, 8, 43, 85. Blood will be collected at baseline and at days 2, 4, 8, 43, 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2010 (estimated)
- Study startAug 2010
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Squamous CellStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Cliniques Universitaires UCL de Mont-Godinne, Dr Joseph Kerger, Cliniques Saint-Pierre Ottignies, Dr Lionel Duck
- Investigators
- Baurain Jean-Francois, Md,PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129154
- Sponsor's protocol ID
- Luc 09-002
- Acronym
- PASCE
- Status last verified
- Aug 2010
- First submitted
- 21 May 2010
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)
- ClinicalTrials.gov ID
- NCT01129154
- Acronym / sponsor ID
- PASCE / Luc 09-002
- Conditions
- Carcinoma, Squamous Cell
- Keywords
- Squamous cell carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Cliniques Universitaires UCL de Mont-Godinne, Dr Joseph Kerger, Cliniques Saint-Pierre Ottignies, Dr Lionel Duck
- Study start
- Aug 2010
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 24 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Squamous Cell Carcinoma (SCC) is one of the most common malignancies in caucasian population. The effect of the immune system on the development of skin tumors has been demonstrated in transplant patients taking immunosuppressive agents (65 fold risk increase). It has been reported that activation of EGFR and RAS signaling pathways play an important role in disease progression maybe through downregulation of the immune system.
The investigators want to treat unresectable SCC patients with an antibody against EGFR (Vectibix®, panitumumab). This antibody induces tumor regression in metastatic colorectal cancer and has been approved as single agent for this indication.
The investigators want to measure the response rate but also analyze the modification of expression profile of some key proteins involved or supposed to be involved in the signaling pathways of EGFR and in the regulation of the immune system. Chemokines such as CCL27 have been shown to play a critical role in the skin-associated immune response by regulating T cell homing. Pivarcsi et al have reported that downregulation of CCL27 is mediated by activation of EGFR/RAS/MAPK signaling pathways.
Detailed description
This is an open-label, multicentric study of 17 patients with skin squamous cancer cell.
Eligible patients should not be suitable for immediate surgery. If they have only one tumor, it should be greater than 3 cm2 in order to allow multiple biopsies.
Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
Patients will be assessed at baseline, at week 6 and then every 12 weeks till progression. In addition to clinical examination, evaluation tools will include photography and CT-scan, MRI or PET-scan.
Skin and tumor biopsies will be performed during first cycle at baseline and at days 2, 4, 8, 43, 85. Blood collections for translational research will be done during first cycle at baseline and at days 2, 4, 8,15, 43, 85. Blood collection for hematology and chemistry assessment will be done each 4weeks.
Patients presenting with a stable disease or a tumor response at week 12 will be eligible for maintenance cycles consisting in an infusion of panitumumab every 2 weeks till progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| panitumumab | Experimental | Drug: infusions of PanitumumabPatients will receive six infusions of panitumumab every 2 weeks for the first cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient with histologically confirmed diagnosis of SCC.
- Patient must not be candidate to direct curative surgery.
- Tumor evaluation by photography with a ruler and CT-scan, MRI or PET-scan must be performed before enrollment.
- Age ≥ 18 years.
- Karnofsky Performance status (KPS) ≥70.
Key exclusion criteria (8 listed)
- Clinically significant cardiovascular disease (including cardiac insufficiency NYHA grade III and IV, unstable angina, arrythmia, myocardial infarction, symptomatic congestive heart failure)in the past 12 months before enrollment.
- History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
- No prior chemotherapy.
- Prior anti-EGFR therapy.
- Radiation within four weeks prior to trial entry.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| infusions of PanitumumabAlso: Vectibix®Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier. | Drug | panitumumab |
Primary outcome
Overall Response Rate (ORR)
Time frame: via imaging every 12 weeks
To measure the efficacy of Panitumumab for SCC in terms of Overall Response Rate (ORR). Overall Response Rate (ORR) is defined as the sum of complete and partial tumour responses seen, divided by the total number of evaluable patients.
4 secondary outcomes
To assess the safety profile of panitumumab in SCC
Time frame: at each visit
Time to treatment failure (TTF)and Time to treatment progression TTP
Time frame: via imaging, every 12 weeks
To measure the duration of response.
Time frame: via imaging, every 12 weeks
To explore the gene expression profiles in SCC under panitumumab treatment (i.e CCL27, EGFR,…).
Time frame: Skin and tumor biopsies will be performed at baseline and at days 2, 4, 8, 43, 85. Blood will be collected at baseline and at days 2, 4, 8, 43, 85
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baurain Jean-Francois, Md,PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing infusions of Panitumumab in people with Carcinoma, Squamous Cell, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baurain Jean-François, MD, PhD (+32 2 7645427, jean-francois.baurain@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (ORR) (time frame: via imaging every 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2010.