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Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Head and Neck Cancer

Thank you

Trial Information

Preemptive Therapy Study of Cetuximab(Erbitux®)Induced Skin Rash Using Doxycycline, Sunscreen, Hydrocortisone and Moisturizer in Colorectal and Head and Neck Cancer Patients


Of the 100 subjects who will participate in this study, 50 will be in the extensive
treatment group and 50 will be in the standard care group. Subjects in the extensive
treatment group will use Doxycycline capsule, 100 mg, taken twice daily, sunscreen SPF 30 or
higher, moisturizer applied to the face, hands, feet, neck, back, and chest each morning
after sunscreen, hydrocortisone 1% cream applied to the face, hands, feet, neck, back, and
chest each evening.

Subjects will start taking the capsule and applying the creams three days prior to beginning
cetuximab therapy. They will continue this regimen of taking the capsule and applying the
creams for 8 weeks. If they develop severe skin rash as a result of cetuximab therapy, the
study doctor may decide to reduce the amount of the dose of cetuximab that they receive or
prescribe other medicines according to standard treatment recommendations, just as he/she
would if the subject was not participating in this study. Subjects will be monitored at
enrollment, 3 weeks into cetuximab treatment and at the end of cetuximab treatment for
adherence, side effects and quality of life.

The standard care group will not receive preventive treatment, but they will be allowed to
use sunscreen and moisturizer if desired. They, too, will be monitored at enrollment, 3
weeks into cetuximab treatment and at the end of cetuximab treatment for adherence, side
effects and quality of life.

If a subject is assigned to this group and they develop a severe skin rash, the study doctor
will treat their rash according to standard treatment recommendations, which may include
Hydrocortisone 1% cream, Doxycycline capsules or other medications.

There will be a follow-Up period for both extensive treatment and standard care groups. At
6 months, 12 months, 18 months and 24 months, after the end of the subject's 8 week study
treatment period, they will be contacted by telephone or discussed during their routine
clinic visit.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of Rash

Outcome Description:

Evaluate the incidence of cetuximab-induced rash, Compare the severity of cetuximab-induced rash between the extensive treatment group (ETG) and the standard care group (SCG).

Outcome Time Frame:

Change from Baseline, week 3, week 8

Safety Issue:

Yes

Principal Investigator

Rebecca A. Redman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

BCC-OHN-GI-13

NCT ID:

NCT01874860

Start Date:

June 2013

Completion Date:

June 2017

Related Keywords:

  • Colorectal Cancer
  • Head and Neck Cancer
  • Colorectal Neoplasms
  • Exanthema
  • Head and Neck Neoplasms

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202