We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01382407
First Posted: June 27, 2011
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck KGaA
Information provided by (Responsible Party):
Rambam Health Care Campus
June 23, 2011
June 27, 2011
April 27, 2017
July 2011
April 1, 2017   (Final data collection date for primary outcome measure)
Relationship between acne and skin rash [ Time Frame: Within Erbitux treatment period (upto 12 months) ]
To determine whether there is a relationship between acne during adolescence and skin rash during cetuximab treatment?
Not Provided
Complete list of historical versions of study NCT01382407 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 1, 2017
April 1, 2017   (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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01382407
B427CTIL
No
Not Provided
Not Provided
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
April 2017