80 - 90 % of the patients treated with anti-EGFR antibodies (panitumumab or cetuximab) experience skin toxicity, mostly acne like skin rash. A standardized treatment of skin rash is neither established as standard arm for clinical trials nor as guideline for the treatment of skin toxicity in clinical practice. While an improvement of QoL has been demonstrated for panitumumab and cetuximab in comparison to best supportive care the data basis for patient related outcomes regarding skin toxicity deriving from randomized trials is still small. Recent surveys among German oncologist revealed that physicians are reluctant to use oral antibiotics as preemptive treatment . Only 19 out of 110 oncologists stated that they are thinking about using preemptive treatment in patients with acne-like skin rash. Thus, in the present trial two main questions will be addressed: (i) Can preemptive treatment with oral doxycycline be replaced by a sequential skin treatment strategy (i.e. local treatment with erythromycin followed by doxycycline in case of inefficacy = development of acne) without compromising treatment efficacy of skin toxicity treatment? (ii) Comparison of general and skin related QoL between both treatment arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
88
Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
Universitätsklinikum Mannheim, III. Medizinische Klinik
Mannheim, Germany
Percentage of patients developing no skin toxicity ≥ grade 2
Percentage of patients developing no skin toxicity ≥ grade 2 at any time during their first 8-weeks of treatment with panitumumab.
Time frame: 8 weeks
Quality of life
Quality of life will be assessed by standardized skin-related (DLQI) and global quality of life (EORTC QLQ C30. For correlation analyses between the different quality of life scores, the non-parametric test according to Spearman will preferably be applied.
Time frame: 8 weeks
Assess Skin toxicity
Assess different skin toxicity grading scales (i.e. NCI CTC v. 4.0; WoMo score; MESTT)
Time frame: 8 weeks
Correlation between skin-related and global quality of life
Description of correlation between skin-related and global quality of life using EORTC-QLQ C30 and SF-36.
Time frame: 8 weeks
late skin toxicity
Describe the development of late skin toxicity after 8 weeks
Time frame: from week 8 to 12
Skin-toxicity related dose reductions of panitumumab
Rate of skin-toxicity induced dose reductions (including withdrawal) of panitumumab
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.