Comparison of Two Preemptive Treatment Strategies of Panitumumab Mediated Skin Toxicity and Assessment of QoL in Patient With Ras-wt Colorectal Cancer
Ras-wildtype Colorectal Cancer
About this trial
This is an interventional prevention trial for Ras-wildtype Colorectal Cancer focused on measuring Can preemptive treatment of panitumumab mediated skin, toxicity with oral doxycycline be replaced by local treatment with erythromycin?, Panitumumab
Eligibility Criteria
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
Sites / Locations
- Universitätsklinikum Mannheim, III. Medizinische Klinik
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Erythromycin
Doxycyline
Experimental Arm (ARM A) skin- treatment: erythromycin cream 2% daily at bedtime doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2 skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks
Standard Arm (ARM B) skin- treatment:doxycycline 100mg b.i.d. skin moisturizer daily at morning, sunscreen before going outdoors for 8 weeks