Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01382407
First received: June 23, 2011
Last updated: May 11, 2015
Last verified: May 2015

June 23, 2011
May 11, 2015
July 2011
March 2016   (final data collection date for primary outcome measure)
Relationship between acne and skin rash [ Time Frame: Within Erbitux treatment period (upto 12 months) ] [ Designated as safety issue: No ]
To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?
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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.
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
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.
 
Active, not recruiting
100
April 2017
March 2016   (final data collection date for primary outcome measure)

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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01382407
B427CTIL
No
Not Provided
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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
May 2015

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