Back to resultsStudy About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors (DIPROCOL)
Primary Purpose
Metastatic Colorectal Cancer, Non-Small-Cell Lung Carcinoma
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Diprosone
Sponsored by
About this trial
This is an interventional prevention trial for Metastatic Colorectal Cancer focused on measuring EGF-R inhibitors
Eligibility 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
Sites / Locations
- Centre Oscar Lambret
- Centre Hospitalier Regional
- Centre Hospitalier Régional
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
DIPROSONE
Arm Description
Outcomes
Primary Outcome Measures
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 Measures
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
Full Information
NCT ID
NCT00910676
First Posted
May 29, 2009
Last Updated
July 30, 2012
Sponsor
Centre Oscar Lambret
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT00910676
Brief Title
Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Roche Pharma AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer, Non-Small-Cell Lung Carcinoma
Keywords
EGF-R inhibitors
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DIPROSONE
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Diprosone
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Time Frame
2 months of treatment by corticotherapy
Secondary Outcome Measure Information:
Title
To assess the frequency of grade I, II and III folliculitis under Cetuximab and under Erlotinib
Time Frame
2 months of treatment
Title
To list the cutaneous side effects of the EGF-R inhibitors
Time Frame
2 months of treatment
Title
To assess the patient quality of life with the DLQI questionnaire
Time Frame
2 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent MORTIER, MD
Organizational Affiliation
Centre Hospitalier Régional et Universitaire de LILLE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Hospitalier Regional
City
Lille
ZIP/Postal Code
59035
Country
France
Facility Name
Centre Hospitalier Régional
City
Lille
ZIP/Postal Code
59035
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study About Preventive Treatment of Folliculitis Induced by Epidermal Growth Factor Receptor Inhibitors
We'll reach out to this number within 24 hrs