Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rambam Health Care Campus
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Treatments: Cetuximab

Criteria

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.