Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)
PASCE
An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)
1 other identifier
interventional
17
1 country
3
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2010
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2010
CompletedFirst Posted
Study publicly available on registry
May 24, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedAugust 30, 2010
August 1, 2010
1.9 years
May 21, 2010
August 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
via imaging every 12 weeks
Secondary Outcomes (4)
To assess the safety profile of panitumumab in SCC
at each visit
Time to treatment failure (TTF)and Time to treatment progression TTP
via imaging, every 12 weeks
To measure the duration of response.
via imaging, every 12 weeks
To explore the gene expression profiles in SCC under panitumumab treatment (i.e CCL27, EGFR,…).
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
Study Arms (1)
panitumumab
EXPERIMENTALPatients will receive six infusions of panitumumab every 2 weeks for the first cycle.
Interventions
Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
Eligibility Criteria
You may qualify if:
- 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:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Cliniques Universitaires Saint-Luc Université Catholique de Louvain
Brussels, Brussels Capital, 1200, Belgium
Cliniques Universitaires UCL
Mont Godinne, 5530, Belgium
Cliniques Saint-Pierre
Ottignies, 1340, Belgium
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baurain Jean-Francois, Md,PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 21, 2010
First Posted
May 24, 2010
Study Start
August 1, 2010
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
August 30, 2010
Record last verified: 2010-08