Trial Information
Phase II Multicentric Study About Preventive Treatment of Folliculitis Induced by the EGF-R Inhibitors in Patients With Metastatic Colorectal Cancer and Treated by Cetuximab or With Non-small-cell Lung Carcinoma Treated by Erlotinib
Inclusion Criteria:
- Indication of Cetuximab in patients with metastatic colorectal cancer in association
or not with irinotecan, after failure of a chemotherapy treatment with Irinotecan OR
- Indication of Erlotinib, in patients with metastatic Non-Small-Cell Lung Carcinoma,
after failure of at least one chemotherapy treatment
- No pre-existing cutaneous toxicity
Exclusion Criteria:
- Contraindication to local corticotherapy
- Previous history of severe hypersensibility reactions (Grade III or IV) due to
Cetuximab, Irinotecan or Erlotinib
- Betamethasone or one of excipient product allergy
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
To reduce by 30 % the frequency of folliculitis by a local corticotherapy beginning at the same time that the treatment by EGF-R inhibitors began
Outcome Time Frame:
2 months of treatment by corticotherapy
Safety Issue:
No
Principal Investigator
Laurent MORTIER, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Centre Hospitalier Régional et Universitaire de LILLE
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
2007-002913-38
NCT ID:
NCT00910676
Start Date:
October 2007
Completion Date:
March 2009
Related Keywords:
- Metastatic Colorectal Cancer
- Non-Small-Cell Lung Carcinoma
- EGF-R inhibitors
- Carcinoma
- Carcinoma, Non-Small-Cell Lung
- Colorectal Neoplasms
- Folliculitis
- Lung Neoplasms