Overview

This trial is active, not recruiting.

Condition colorectal cancer metastatic
Treatment cetuximab
Target EGFR
Sponsor Rambam Health Care Campus
Collaborator Merck KGaA
Start date July 2011
End date March 2016
Trial size 100 participants
Trial identifier NCT01382407, B427CTIL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.
cetuximab Erbitux
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.

Primary Outcomes

Measure
Relationship between acne and skin rash
time frame: Within Erbitux treatment period (upto 12 months)

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?
Principal investigator Gil Bar-Sela, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Rambam Health Care Campus.