An open label multicentric phase II study of Panitumumab (Vectibix®) in cutaneous squamous cell carcinoma (SCC) - PASCE

Phase 1

Conditions: Cutaneous Squamous Cell Carcinoma (SCC)
MedDRA version: 12.1Level: LLTClassification code 10041823Term: Squamous cell carcinoma
MedDRA version: 12.1Level: PTClassification code 10041823Term: Squamous cell carcinoma

Registration Number: EUCTR2009-015237-76-BE

Lead Sponsor: Centre du Cancer des Cliniques Universitaires Saint-Luc

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 17

Inclusion Criteria

1. Patient with histologically confirmed diagnosis of SCC.
2. Patient must not be candidate to direct curative surgery.
3.Tumor evaluation by photography with a ruler and CT-scan, MRI or PET-scan must be performed before enrollment.
4. Age = 18 years.
5. Karnosky Performance status (KPS) =70.
6. 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)
7. Patient should agree to perform biopsies and blood collections for translational research.
8. Signed informed consent from the patient or legal representative must be obtained.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. 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.
2. History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
3. No prior chemotherapy.
4. Prior anti-EGFR therapy.
5. Radiation within four weeks prior to trial entry.
6. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
7. 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.
8. The patient has (or has had) previous or concomitant malignancies at other sites whitin last 5years, except effectively treated malignancy that is considered by the investigator highly likely to have been cured.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Overall Response Rate (ORR);Secondary Objective: Toxicity of Panitumumab in SCC<br>Time to treatment failure (TTF)<br>Time To Progression (TTP)<br>Duration of response<br>Analysis of expression profile in SCC under panitumumab treatment (ie CCl27, EGFR,...);Primary end point(s): - ORR wiOverall Response Rate (ORR). Imaging evaluation will be done via photography and CT-scan, MRI or PET-scan every 6 weeks on 2 occasions, then every 12 weeks. The evaluation at week 6 is only informative. Patient will be declared progressive at that time if their clinical situation requires an immediate alternative treatment. Response evaluation will be assessed at week 12. Best observed response will also be recorded.

Secondary Outcome Measures