Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Colorectal Cancer Metastatic Clinical Trial

Official title:

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01382407
• Other study ID #: B427CTIL
• Status: Completed
• Phase: N/A
• First received: June 23, 2011
• Last updated: April 26, 2017
• Start date: July 2011
• Est. completion date: April 1, 2017

Study information

• Verified date: April 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Drug:
• Cetuximab
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.

Locations

Country	Name	City	State
Israel	Oncology Institute, Rambam Health Care Campus	Haifa
Israel	Rambam Health Care Campus	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Merck KGaA

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between acne and skin rash	To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?	Within Erbitux treatment period (upto 12 months)