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Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Colon Cancer

Thank you

Trial Information


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Main criteria is the variation of skin pro-inflammatory cytokines in pre and post-therapeutic punch skin biopsies

Safety Issue:

Yes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CUTACETUX 2010-0198378-85

NCT ID:

NCT01292356

Start Date:

December 2010

Completion Date:

Related Keywords:

  • Metastatic Colon Cancer
  • Colonic Neoplasms

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