Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01382407

Enrollment

100

Registered

2011-06-27

Start date

2011-07-31

Completion date

2017-04-01

Last updated

2017-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer Metastatic

Keywords

skin rash reaction, ERBITUX® (cetuximab), acne

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

Interventions

DRUGCetuximab

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.

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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?

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026