Cutaneous Squamous Cell Carcinoma (SCC) MedDRA version: 12.1 Level: LLT Classification code 10041823 Term: Squamous cell carcinoma MedDRA version: 12.1 Level: PT Classification code 10041823 Term: Squamous cell carcinoma
Conditions
Interventions
Trade Name: Vectibix®
Product Name: Panitumumab
Product Code: Not applicable
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PANITUMUMAB
CAS Number: 339177-26-3
Other d
Sponsors
Centre du Cancer des Cliniques Universitaires Saint-Luc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Response Rate (ORR);Secondary Objective: Toxicity of Panitumumab in SCC Time to treatment failure (TTF) Time To Progression (TTP) Duration of response 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. | — |
Countries
Belgium
Outcome results
None listed