STLDD-1
Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment
Sponsor study identifier
observational
40
1 country
1
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 22, 2011
Actual (reported)June 27, 2011
Actual (reported)September 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
number of patients with a severe skin toxicity
8 weeks
total occurence of skin toxicities
8 weeks
number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity
8 weeks
quality of life assessed with DLQI
8 weeks
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
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.
Department of Gastrointestinal Cancer, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Warsaw, Masovian Voivodeship, 02-781, Poland
Lucjan S Wyrwicz, MD,PhD
Maria Sklodowska-Curie National Research Institute of Oncology
First Submitted
June 22, 2011
First Posted
June 27, 2011
Study Start
June 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2011
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2011
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 27, 2011
Record last verified: 2011-06
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Source: ClinicalTrials.gov.
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