Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors (DIPROCOL)

Centre Oscar Lambret

Status and phase: Completed; Phase 2

Conditions: Non-Small-Cell Lung Carcinoma; Metastatic Colorectal Cancer

Treatments: Drug: Diprosone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00910676

2007-002913-38

Details and patient eligibility

About

Patients will receive local prophylactic treatment (Diprosone cream) during 8 weeks from the beginning of the EGF-R inhibitors treatment, on the areas of the body susceptible to be affected by folliculitis.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

DIPROSONE

Experimental group

Treatment:

Drug: Diprosone