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What is the primary objective of this study?

The purpose of this study is to determine if using preventive treatments such as Doxycycline (an anti-biotic) capsules, sunscreen with SPF 30, Hydrocortisone 1% cream and a moisturizer will help to reduce the incidence and severity of the skin rash associated with Cetuximab (Erbitux®) when compared to receiving standard care for the treatment of skin rash.

Who is eligible to participate?

Inclusion Criteria: 1. Age greater than or equal to 18 years 2. Diagnosis of colorectal or head and neck cancer 3. Receipt of at least one dose of cetuximab during the study time period Exclusion Criteria: 1. Prior cetuximab treatment within the 6 months of study initiation 2. Current treatment with tyrosine kinase inhibitors 3. Patients who are pregnant or incarcerated

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Colorectal Cancer

Head and Neck Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DoxycyclineDoxycycline capsule, 100 mg, taken twice daily

Drug:Hydrocortisone 1% creamApplied to the face, hands, feet, neck, back, and chest each evening (Topical cream)

Other:SunscreenApplied to exposed skin areas at least 30 minutes before going outdoors each morning.

Other:MoisturizerApplied to the face, hands, feet, neck, back, and chest each morning after sunscreen

Drug:ClindamycinRecommended for daily use if rash returns (Topical cream)

Drug:Medrol-dose pack (Steroid)Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Extensive treatment groupDoxycycline capsule, 100 mg, taken twice daily; sunscreen SPF 30 or higher applied to exposed skin areas at least 30 minutes before going outdoors each morning; moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen; Hydrocortisone 1% topical cream applied to the face, hands, feet, neck, back, and chest each evening. For patients with grade 1 rash, hydrocortisone 1% cream and clindamycin 1% gel (tetracycline antibiotic) are recommended for daily use. For patients with grade 2 rash, hydrocortisone cream and doxycycline 100mg twice daily or minocycline (tetracycline antibiotic) 100mg once daily is recommended. For patients with grade 3 rash, systemic steroid therapy (a Medrol dose-pack) will be added to the grade 2 treatment.

Standard care groupPatient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.

Study Status

Recruiting

Start Date: August 2013

Completed Date: August 2022

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Incidence of Rash

Secondary Outcome: Quality of Life (QOL)

Study sponsors, principal investigator, and references

Principal Investigator: Rebecca A. Redman, MD

Lead Sponsor: University of Louisville

Collaborator: James Graham Brown Cancer Center

More information:https://clinicaltrials.gov/show/NCT01874860