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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer, Non-Small-Cell Lung Carcinoma

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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

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