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Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

This study is not yet open for participant recruitment.
Verified June 2011 by Rambam Health Care Campus
Sponsor:
Collaborator:
Merck KGaA
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01382407
First received: June 23, 2011
Last updated: June 24, 2011
Last verified: June 2011
History of Changes

June 23, 2011
June 24, 2011
July 2011
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Complete list of historical versions of study NCT01382407 on ClinicalTrials.gov Archive Site
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Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab
Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

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.
Colorectal Cancer Metastatic
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.
Other Name: Erbitux
Cetuximab
All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.
Intervention: Drug: Cetuximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
June 2013
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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.
Both
18 Years and older
No
Contact: Gil Bar-Sela, M.D. +972-4-8543810 g_barsela@rambam.health.gov.il
Israel
 
NCT01382407
B427CTIL
No
Gil Bar-Sela , MD, Rambam Health Care Campus
Rambam Health Care Campus
Merck KGaA
Principal Investigator: Gil Bar-Sela, M.D. Rambam Health Care Campus
Rambam Health Care Campus
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP