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Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Information source: Rambam Health Care Campus
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer Metastatic

Intervention: Cetuximab (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Rambam Health Care Campus

Official(s) and/or principal investigator(s):
Gil Bar-Sela, M.D., Principal Investigator, Affiliation: Rambam Health Care Campus

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.

Clinical Details

Official title: Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: Relationship between acne and skin rash

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Oncology Institute, Rambam Health Care Campus, Haifa 31096, Israel

Rambam Health Care Campus, Haifa 31096, Israel

Additional Information

Starting date: July 2011
Last updated: May 11, 2015

Page last updated: August 20, 2015

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