An observational study in Colorectal Cancer and Skin Toxicities, sponsored by Maria Sklodowska-Curie National Research Institute of Oncology. Status unknown at 1 site in Poland. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-06-27.
Sponsored by Maria Sklodowska-Curie National Research Institute of Oncology · Observational
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 40 is below the median of 250 across 1,226 observational studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Maria Sklodowska-Curie National Research Institute of Oncology is the lead sponsor of 63 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with metastatic colorectal cancer, qualified to either cetuximab or panitumumab based systemic treatment (either monotherapy or with chemotherapy) receiving a 100 mg of doxycycline daily.
Exclusion Criteria:
Patients with metastatic colorectal cancer, qualified to either cetuximab or panitumumab based systemic treatment (either monotherapy or with chemotherapy) receiving a 100 mg of doxycycline daily
number of patients with a severe skin toxicity
Time frame: 8 weeks
total occurence of skin toxicities
analyzed for weeks: 2, 4, 6 and 8 separetly
Time frame: 8 weeks
number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity
Time frame: 8 weeks
quality of life assessed with DLQI
assessed as a correlation to severeness of skin toxicities
Time frame: 8 weeks
This study is status unknown, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Maria Sklodowska-Curie National Research Institute of Oncology