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

Metastatic Colorectal Cancer Clinical Trial

— DIPROCOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00910676
• Other study ID #: 2007-002913-38
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2009
• Last updated: July 30, 2012
• Start date: October 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2012
• Source: Centre Oscar Lambret
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00960388

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Colorectal Neoplasms
• Folliculitis
• Lung Neoplasms
• Metastatic Colorectal Cancer
• Non-Small-Cell Lung Carcinoma

Intervention

Drug:
• Diprosone
Start of treatment: as soon as the EGF-R inhibitors treatment begins Application: On the body area susceptible to be affected by folliculitis, once a day, in the evening Dosage: Quantity corresponded to around 2 tubes of 30 grams a week on the face, the chest and upper side of the back. There is no maximum dosage. Period of treatment: 8 weeks

Locations

Country	Name	City	State
France	Centre Hospitalier Regional	Lille
France	Centre Hospitalier Régional	Lille
France	Centre Oscar Lambret	Lille

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Roche Pharma AG

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		2 months of treatment by corticotherapy	No
Secondary	To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib		2 months of treatment	No
Secondary	To list the cutaneous side effects of the EGF-R inhibitors		2 months of treatment	Yes
Secondary	To assess the patient quality of life with the DLQI questionnaire		2 months of treatment	No