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

Primary Purpose

Carcinoma, Squamous Cell

Status

Unknown status

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

infusions of Panitumumab

About this trial

This is an interventional treatment trial for Carcinoma, Squamous Cell focused on measuring Squamous cell carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cliniques Universitaires Saint-Luc Université Catholique de LouvainRecruiting
Cliniques Universitaires UCLRecruiting
Cliniques Saint-PierreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

panitumumab

Arm Description

Patients will receive six infusions of panitumumab every 2 weeks for the first cycle.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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).

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.

Full Information

NCT ID

NCT01129154

First Posted

May 21, 2010

Last Updated

August 27, 2010

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Cliniques Universitaires UCL de Mont-Godinne, Dr Joseph Kerger, Cliniques Saint-Pierre Ottignies, Dr Lionel Duck

1. Study Identification

Unique Protocol Identification Number

NCT01129154

Brief Title

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

Acronym

PASCE

Official Title

An Open Label Multicentric Phase II Study of Panitumumab (Vectibix®) in Cutaneous Squamous Cell Carcinoma (SCC)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Unknown status

Study Start Date

August 2010 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

Cliniques Universitaires UCL de Mont-Godinne, Dr Joseph Kerger, Cliniques Saint-Pierre Ottignies, Dr Lionel Duck

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Squamous Cell

Keywords

Squamous cell carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

17 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

panitumumab

Arm Type

Experimental

Arm Description

Patients will receive six infusions of panitumumab every 2 weeks for the first cycle.

Intervention Type

Drug

Intervention Name(s)

infusions of Panitumumab

Other Intervention Name(s)

Vectibix®

Intervention Description

Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

Time Frame

via imaging every 12 weeks

Secondary Outcome Measure Information:

Title

To assess the safety profile of panitumumab in SCC

Description

Time Frame

at each visit

Title

Time to treatment failure (TTF)and Time to treatment progression TTP

Description

Time Frame

via imaging, every 12 weeks

Title

To measure the duration of response.

Description

Time Frame

via imaging, every 12 weeks

Title

To explore the gene expression profiles in SCC under panitumumab treatment (i.e CCL27, EGFR,…).

Description

Results will be presented as proportion of each expression type.

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Baurain Jean-François, MD, PhD

Phone

+32 2 7645427

jean-francois.baurain@uclouvain.be

First Name & Middle Initial & Last Name or Official Title & Degree

Duquenne Aline, MSc

Phone

+32 2 7645427

aline.duquenne@uclouvain.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Baurain Jean-Francois, Md,PhD

Organizational Affiliation

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cliniques Universitaires Saint-Luc Université Catholique de Louvain

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Baurain Jean-Francois, Md,PhD

Phone

+32 2 7645427

jean-françois.baurain@uclouvain.be

First Name & Middle Initial & Last Name & Degree

Duquenne Aline, MSc

Phone

+32 2 764 5427

aline.duquenne@uclouvain.be

Facility Name

Cliniques Universitaires UCL

City

Mont Godinne

ZIP/Postal Code

5530

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kerger Joseph, MD, PhD

Phone

+32 81423328

Facility Name

Cliniques Saint-Pierre

City

Ottignies

ZIP/Postal Code

1340

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Duck Lionel, MD

Phone

+32 10414953

12. IPD Sharing Statement

Learn more about this trial

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

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