Colorectal Cancer Clinical Trial
Official title:
Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment
Up to 60% of patients with metastatic colorectal cancer can be treated with one of
monoclonal antibodies targeted against epidermal growth factor receptor (EGFR). This
treatment is associated with a specific spectrum of toxicity: acne-like rash from limited up
to erythema, often with severe pruritus, sometimes combined with other types of skin
toxicities (hair and nail changes). Previously in STEPP study investigators shown that
pre-emptive treatment with oral doxycycline (200 mg daily), topical steroids and sun
blockers reduces the number of more severe skin side effects of panitumumab.
The study is designed to described the profile of skin toxicity of EGFR blocking drugs
combined with low-dose doxycycline (100 mg daily) used in the pre-emptive manner.
Patients with metastatic colorectal cancer treated with cetuximab or panitumumab usually
develop the skin toxicity which can impair patients' quality of life as well as limit the
treatment. We designed this trial to assess the effect of simplified protocol of pre-emptive
treatment on the observed skin toxicities during cetuximab and panitumumab treatment of
colorectal cancer.
The study is a cohort observational, single center study which should result in estimation
of particular types of toxicities, especially occurence of more severe (grade 2 and 3) side
effects and assess the tolerance of doxycyline in the prolonged administration.
The observation in the study is biweekly and is continued up to 8 weeks.
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Observational Model: Cohort, Time Perspective: Prospective
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