Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Completed

• Conditions: Colorectal Cancer Metastatic
• Interventions: Drug: Cetuximab

• Registration Number: NCT01382407
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-06-23
• Study First Submitted QC: 2011-06-24
• Study First Posted: 2011-06-27
• Study Start: 2011-07
• Status Verified: 2017-04
• Primary Completion: 2017-04-01
• Study Completion: 2017-04-01
• Last Update Submitted: 2017-04-26
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cetuximab	Cetuximab	All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.

Primary Outcome Measures

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

Trial Locations

Locations (2)

Oncology Institute, Rambam Health Care Campus; 🇮🇱 Haifa, Israel

Rambam Health Care Campus; 🇮🇱 Haifa, Israel