Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer

Inclusion criteria

• Patients with wild-type RAS (KRAS and NRAS) status of metastatic colorectal cancer treatment with panitumumab according to label

• RAS wild-type tested in
• KRAS exon 2 (codons 12/13)
• KRAS exon 3 (codons 59/61)
• KRAS exon 4 (codons 117/146)
• NRAS exon 2 (codons 12/13)
• NRAS exon 3 (codons 59/61)
• NRAS exon 4 (codons 117/146)
• treatment with pre-emptive study medication shall begin the day before treatment start with panitumumab
• Willingness to cope with biweekly quality of life questionnaires
• Written Informed consent
• Aged at least 18 years
• ECOG Performance Status 0-2
• Life expectancy of at least 12 weeks
• Adequate haematological, hepatic, renal and metabolic function parameters:

• Leukocytes > 3000/mm³
• ANC ≥ 1500/mm³
• Platelets ≥ 100,000/mm³
• Haemoglobin > 9 g/dl
• Serum creatinine ≤ 1.5 x ULN
• Bilirubin ≤ 1.5 x ULN
• GOT-GPT ≤ 2.5 x ULN (in case of liver metastases GOT / GPT ≤ 5 x ULN)
• AP ≤ 5 x ULN
• Magnesium, Calcium and potassium within normal ranges (may be substituted before study entry)

Exclusion criteria

• Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
• Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
• Serious concurrent diseases
• On-treatment participation in a clinical study in the period 30 days prior to inclusion
• Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrolment.
• History of interstitial lung disease, e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
• History of HIV infection.
• Other previous or concurrent malignancy (≤ 5 years prior to enrolment in study) except non-melanoma skin cancer or cervical carcinoma FIGO stage 0- 1 if the patient is continuously disease-free
• Known allergic reactions on panitumumab, doxycycline or erythromycin
• Previous treatment with anti-cancer agents directed against EGFR (e.g. cetuximab, panitumumab, erlotinib, gefitinib, lapatinib)
• Skin rash existing before or due to other reasons than panitumumab treatment
• Other dermatologic disease that may interfere with correct grading of panitumumab induced skin rash
• Parallel treatment with anti-tumor agents other than panitumumab