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Brief Title: Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream
Official Title: A Double Blind Placebo Controlled Randomized Phase II Study Evaluating the Efficacy and Safety of the Prophylactic Use of Doxycycline +/- Vitamin K Cream in First Line mCRC Patients Treated With Erbitux and FOLFIRI.
Study ID: NCT01345526
Brief Summary: The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.
Detailed Description: The aim of this Phase 2, two-arm, randomized, double blind placebo controlled study is to evaluate the efficacy of combination therapy of doxycycline and Vitamin K1 compared to doxycycline plus placebo for the prevention of acne-like skin rash in mCRC patients receiving first line cetuximab treatment.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Unversity Hospital Mannheim, Mannheim, , Germany
Institute of Oncology Ljubljana, Ljubljana, , Slovenia
Name: Ralf Hofheinz, Prof.
Affiliation: Universitätsmedizin Mannheim
Role: STUDY_CHAIR