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Completed

NCT Number: NCT01382407

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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Key information

Conditions

Colorectal Cancer Metastatic Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oncology Institute, Rambam Health Care Campus, Haifa, Israel

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cetuximab

Drug

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 names: Erbitux

Primary outcomes

  1. 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?

Sponsors and collaborators

Lead sponsor

Rambam Health Care Campus

Other

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study title

Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab?

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2011
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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