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Colorectal Cancer Metastatic | Does Acne Rash During Adolescence Predict Skin Reaction to Cetuximab

Colorectal Cancer Metastatic research study

What is the primary objective of 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 is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Colorectal Cancer Metastatic

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:CetuximabOnce 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CetuximabAll patients who started treatment with ERBITUX® (cetuximab), as a single agent or in combination with chemotherapy.

Study Status

Completed

Start Date: July 2011

Completed Date: April 1, 2017

Phase: N/A

Type: Observational

Design:

Primary Outcome: Relationship between acne and skin rash

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Gil Bar-Sela, M.D.

Lead Sponsor: Rambam Health Care Campus

Collaborator: Merck KGaA

More information:https://clinicaltrials.gov/show/NCT01382407

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