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
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