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

NCT ID: NCT00910676

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Colorectal Cancer Non-Small-Cell Lung Carcinoma

Keywords

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EGF-R inhibitors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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DIPROSONE

Group Type EXPERIMENTAL

Diprosone

Intervention Type DRUG

* 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roche Pharma AG

INDUSTRY

Sponsor Role collaborator

Centre Oscar Lambret

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Laurent MORTIER, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Régional et Universitaire de LILLE

Locations

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Centre Oscar Lambret

Lille, , France

Site Status

Centre Hospitalier Regional

Lille, , France

Site Status

Centre Hospitalier Régional

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2007-002913-38

Identifier Type: -

Identifier Source: org_study_id

NCT00960388

Identifier Type: -

Identifier Source: nct_alias