Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response
Primary Purpose
Metastatic Colon Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Colon Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years
- Patient with histologically proven metastatic colorectal cancer with KRAS wild-type
- Treatment with cetuximab in first line chemotherapy combined with FOLFOX or FOLFIRI
- Patient has signed informed consent
- Patient affiliated to the Social Security
- Prescription of cetuximab in agreement with the Summary of Product Characteristics
Exclusion Criteria:
- Patients aged under 18
- Patients taking immunosuppressive therapy
- Patient having a severe skin disease
- No measurable metastasis
- Patients with a contra-indication of cetuximab: hypersensitivity to cetuximab or to any excipients
- Severe alteration of respiratory or cardiac function or severe coronary disease
- Patients with contra-indication to chemotherapy FOLFOX and FOLFIRI
- Participation in another research protocol
- Patients not affiliated to the Social Security
- Hospitalized patients without consent
- Pregnant or nursing women, women of childbearing age with no effective contraception
Sites / Locations
- Chu de Poitiers
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cetuximab
Arm Description
Outcomes
Primary Outcome Measures
Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies
Secondary Outcome Measures
Full Information
NCT ID
NCT01292356
First Posted
February 7, 2011
Last Updated
April 4, 2017
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01292356
Brief Title
Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 20, 2010 (Actual)
Primary Completion Date
March 3, 2016 (Actual)
Study Completion Date
March 3, 2016 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
Brief Summary
Colon cancer is one of the most common cancers in France with more than 36,000 new cases per year. Despite significant advances in therapeutic care, the prognosis of colon cancers with metastases remains bad. The treatment of metastatic disease is based on chemotherapy coupled with therapeutic antibodies. The most commonly used are anti-EGFR (Epidermal Growth Factor Receptor), which allowed a significant increase in patient survival. They are responsible for skin toxicity in the form of an acneiform rash which can be debilitating for patients and require discontinuation of treatment. However, this toxicity is strongly correlated with treatment efficacy. Understanding the mechanisms of cutaneous side effects of anti-EGFR is therefore a major challenge to treat and better understand the association with treatment efficacy.
The objective of this study is to investigate a link between cutaneous inflammatory response in patients treated with anti-EGFR, serum level of anti-EGFR and treatment efficacy. It will be conducted systematic consultations dermatology, skin biopsies and blood samples in patients treated with anti-EGFR. From biopsies, it will be searched by an infiltration of inflammatory cells and expression of genes involved in skin inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colon Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cetuximab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
cetuximab
Primary Outcome Measure Information:
Title
Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years
Patient with histologically proven metastatic colorectal cancer with KRAS wild-type
Treatment with cetuximab in first line chemotherapy combined with FOLFOX or FOLFIRI
Patient has signed informed consent
Patient affiliated to the Social Security
Prescription of cetuximab in agreement with the Summary of Product Characteristics
Exclusion Criteria:
Patients aged under 18
Patients taking immunosuppressive therapy
Patient having a severe skin disease
No measurable metastasis
Patients with a contra-indication of cetuximab: hypersensitivity to cetuximab or to any excipients
Severe alteration of respiratory or cardiac function or severe coronary disease
Patients with contra-indication to chemotherapy FOLFOX and FOLFIRI
Participation in another research protocol
Patients not affiliated to the Social Security
Hospitalized patients without consent
Pregnant or nursing women, women of childbearing age with no effective contraception
Facility Information:
Facility Name
Chu de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Skin Toxicity of Cetuximab: Find a Link Between Skin Inflammation and Tumor Response
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