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

Information source: Centre Oscar Lambret
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Colorectal Cancer; Non-Small-Cell Lung Carcinoma

Intervention: Diprosone (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Centre Oscar Lambret

Official(s) and/or principal investigator(s):
Laurent MORTIER, MD, Principal Investigator, Affiliation: Centre Hospitalier RĂ©gional et Universitaire de LILLE

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.

Clinical Details

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

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

Primary outcome: 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

Secondary outcome:

To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib

To list the cutaneous side effects of the EGF-R inhibitors

To assess the patient quality of life with the DLQI questionnaire

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Centre Hospitalier Regional, Lille 59035, France

Centre Hospitalier RĂ©gional, Lille 59035, France

Centre Oscar Lambret, Lille 59020, France

Additional Information

Starting date: October 2007
Last updated: July 30, 2012

Page last updated: August 23, 2015

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