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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
  Purpose
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.

Condition Intervention
Colorectal Cancer Metastatic Drug: Cetuximab

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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?


Enrollment: 100
Study Start Date: July 2011
Study Completion Date: April 1, 2017
Primary Completion Date: April 1, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cetuximab
All patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01382407


Locations
Israel
Oncology Institute, Rambam Health Care Campus
Haifa, Israel, 31096
Rambam Health Care Campus
Haifa, Israel, 31096
Sponsors and Collaborators
Rambam Health Care Campus
Merck KGaA
Investigators
Principal Investigator: Gil Bar-Sela, M.D. Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01382407     History of Changes
Other Study ID Numbers: B427CTIL
First Submitted: June 23, 2011
First Posted: June 27, 2011
Last Update Posted: April 27, 2017
Last Verified: April 2017

Keywords provided by Rambam Health Care Campus:
skin rash reaction
ERBITUX® (cetuximab)
acne

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Cetuximab
Antineoplastic Agents