Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Rambam Health Care Campus

Status: Completed

Conditions: Colorectal Cancer Metastatic

Treatments: Drug: Cetuximab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01382407

B427CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

100 participants in 1 patient group

Cetuximab

Description:

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

Treatment:

Drug: Cetuximab