Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer Metastatic
• Intervention / Treatment: Drug: Cetuximab

Detailed Description

The hypothesis of this study is that patients who suffered from acne vulgaris during adolescence are at greater risk of developing acneiform skin rash due to cetuximab

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Rambam Health Care Campus
  • Haifa, Israel, 31096
    • Oncology Institute, Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients above the age of 18 years, who have been diagnosed with confirmed KRAS-WT mCRC, and are starting treatment with cetuximab, will be informed of the study.

Description

Inclusion Criteria:

• Age above 18 years.
• Histology or cytology proven KRAS-WT mCRC.
• Performance status ≤3 (Eastern Cooperative Oncology Group [ECOG] classification)
• Life expectancy of more than 12 weeks.
• Written informed consent.
• In women of childbearing potential, appropriate contraceptive measures must be used during treatment with cetuximab and for 6 months following the last dose of cetuximab.

Exclusion Criteria:

• Past systemic immune therapy for disease other than cancer.
• Past immune or other target therapy for cancer (not including bevacizumab).
• Presence of acne or acneiform rash prior to starting treatment with cetuximab.
• Patients with treatment plan of cetuximab and capecitabine combination.
• For female patients: the patient is pregnant or lactating.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cetuximab; All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.	Drug: Cetuximab; Once a week:Loading dose-400 mg/m2;subsequent-250 mg/m2 on days 8,15, 22,29,36 if administered as a single agent, or together with Irinotecan 125 mg/m2 on days 1,8,15,29 followed by administration every 42 days.; Other Names: Erbitux

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between acne and skin rash	To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?	Within Erbitux treatment period (upto 12 months)

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Principal Investigator: Gil Bar-Sela, M.D., Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): April 1, 2017

Study Registration Dates

• First Submitted: June 23, 2011
• First Submitted That Met QC Criteria: June 24, 2011
• First Posted (ESTIMATE): June 27, 2011

Study Record Updates

• Last Update Posted (ACTUAL): April 27, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: acne; skin rash reaction; ERBITUX® (cetuximab)
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: B427CTIL