Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab
1 other identifier
observational
100
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2011
CompletedFirst Posted
Study publicly available on registry
June 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedApril 27, 2017
April 1, 2017
5.8 years
June 23, 2011
April 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Cetuximab
All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.
Interventions
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.
Eligibility Criteria
All patients above the age of 18 years, who have been diagnosed with confirmed KRAS-WT mCRC, and are starting treatment with cetuximab, will be informed of the study.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rambam Health Care Campuslead
- Merck KGaA, Darmstadt, Germanycollaborator
Study Sites (2)
Oncology Institute, Rambam Health Care Campus
Haifa, 31096, Israel
Rambam Health Care Campus
Haifa, 31096, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gil Bar-Sela, M.D.
Rambam Health Care Campus
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2011
First Posted
June 27, 2011
Study Start
July 1, 2011
Primary Completion
April 1, 2017
Study Completion
April 1, 2017
Last Updated
April 27, 2017
Record last verified: 2017-04