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 ErlotinibTo 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
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