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

Centre du Cancer des Cliniques Universitaires Saint-Luc0 个研究点目标入组 17 人开始时间: 2010年3月3日最近更新: 2017年4月3日

研究概览

暂无简介。

•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

•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.

发起方

Centre du Cancer des Cliniques Universitaires Saint-Luc