Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment (STLDD-1)

NCT01380262 UNKNOWN

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.

Details

Lead sponsor	Maria Sklodowska-Curie National Research Institute of Oncology
Status	UNKNOWN
Enrolment	40
Start date	2010-06
Completion	2011-09

Conditions

• Colorectal Cancer
• Skin Toxicities

Primary outcomes

• number of patients with a severe skin toxicity — 8 weeks

Countries

Poland