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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
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colon Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 7, 2011
Last Updated
April 4, 2017
Sponsor
Poitiers University Hospital
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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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