Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC) (PASCE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Cliniques Universitaires UCL de Mont-Godinne, Dr Joseph Kerger
Cliniques Saint-Pierre Ottignies, Dr Lionel Duck
Information provided by:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01129154
First received: May 21, 2010
Last updated: August 27, 2010
Last verified: August 2010
  Purpose

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.


Condition Intervention Phase
Carcinoma, Squamous Cell
Drug: infusions of Panitumumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)

Resource links provided by NLM:


Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Overall Response Rate (ORR) [ Time Frame: via imaging every 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To assess the safety profile of panitumumab in SCC [ Time Frame: at each visit ] [ Designated as safety issue: Yes ]
    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.

  • Time to treatment failure (TTF)and Time to treatment progression TTP [ Time Frame: via imaging, every 12 weeks ] [ Designated as safety issue: No ]
    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.

  • To measure the duration of response. [ Time Frame: via imaging, every 12 weeks ] [ Designated as safety issue: No ]
    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).

  • 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 ] [ Designated as safety issue: No ]
    Results will be presented as proportion of each expression type.


Estimated Enrollment: 17
Study Start Date: August 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: panitumumab
Patients will receive six infusions of panitumumab every 2 weeks for the first cycle.
Drug: infusions of Panitumumab
Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
Other Name: Vectibix®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • 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.
  • Signed informed consent from the patient or legal representative must be obtained.

Exclusion criteria

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01129154

Contacts
Contact: Baurain Jean-François, MD, PhD +32 2 7645427 jean-francois.baurain@uclouvain.be
Contact: Duquenne Aline, MSc +32 2 7645427 aline.duquenne@uclouvain.be

Locations
Belgium
Cliniques Universitaires Saint-Luc Université Catholique de Louvain Recruiting
Bruxelles, Belgium, 1200
Contact: Baurain Jean-Francois, Md,PhD    +32 2 7645427    jean-françois.baurain@uclouvain.be   
Contact: Duquenne Aline, MSc    +32 2 764 5427    aline.duquenne@uclouvain.be   
Cliniques Universitaires UCL Recruiting
Mont Godinne, Belgium, 5530
Contact: Kerger Joseph, MD, PhD    +32 81423328      
Cliniques Saint-Pierre Recruiting
Ottignies, Belgium, 1340
Contact: Duck Lionel, MD    +32 10414953      
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Cliniques Universitaires UCL de Mont-Godinne, Dr Joseph Kerger
Cliniques Saint-Pierre Ottignies, Dr Lionel Duck
Investigators
Principal Investigator: Baurain Jean-Francois, Md,PhD Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  More Information

No publications provided

Responsible Party: Baurain Jean-François, Cliniques universitaires Saint-Luc
ClinicalTrials.gov Identifier: NCT01129154     History of Changes
Other Study ID Numbers: Luc 09-002
Study First Received: May 21, 2010
Last Updated: August 27, 2010
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Ethics Committee

Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Squamous cell carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014