Clinical trial NCT01380262: Pre-emptive Low-dose Doxycycline During Anti-EGFR Treatment
Official title: Prospective Phase II Study on Skin Toxicity on Low-Dose Doxycycline in Metastatic Colorectal Cancer Patients During Cetuximab and Panitumumab Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Skin Toxicities
Keywords: Colorectal Cancer
Skin Rash
Pre-emptive treatment
Doxycycline
Anti-EGFR antibody
Cetuximab
Panitumumab
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* diagnosis of metastatic colorectal cancer,
* previously qualified to either cetuximab or panitumumab,
* written consent.

Exclusion Criteria:

* previous administration of cetuximab or panitumumab,
* contradictions to receive oral doxycycline.

Primary outcomes:
measure: number of patients with a severe skin toxicity
timeFrame: 8 weeks
Secondary outcomes:
measure: total occurence of skin toxicities
timeFrame: 8 weeks
measure: number of patients with delayed administration of cetuximab or panitumumab due to severe skin toxicity
timeFrame: 8 weeks
measure: quality of life assessed with DLQI
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Department of Gastrointestinal Cancer, Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
state: Mazowieckie
Study officials:
affiliation: Maria Sklodowska-Curie National Research Institute of Oncology
name: Lucjan S Wyrwicz, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: