SKIP - A Double-blind Placebo-controlled Randomized Multicenter Phase II Trial of Skin Toxicity Treatment in Subjects With Advanced or Metastatic Colorectal Carcinoma Receiving Panitumumab
Because of their frequency and severity panitumumab associated skin toxicities affect
patients' quality of life and thus threaten patients' compliance to therapy. There is an
urgent need for evidence-based treatment recommendations for the prevention and management
of panitumumab -associated skin toxicities.
The study aims to compare the efficacy and safety of a manageable preemptive treatment with
oral doxycycline in combination with a supportive topical regimen containing erythromycin
cream (2 %) over duration of 12 weeks on the occurrence and grade of panitumumab induced
skin toxicities in a double-blind, controlled randomized setting. Basic skin treatment with
or without doxycycline will be discontinued at the end of study treatment after 12 weeks or
until a value of 6-10 is observed on the visual analogue scale (VAS), whichever is sooner.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Time until unblinding of skin therapy allocation (basic skin treatment with or without doxycycline) due to insufficient efficacy (i.e. unbearable skin toxicity, measured by patient's allocating point 6 through 10 on a visual analogue scale)
Hanno Riess, Prof.
Charité Campus Virchow Klinikum, Klinik für Innere Medizin mit Schwerpunkt Hämatologie u. Onkologie
Germany: Federal Institute for Drugs and Medical Devices