Back to resultsSystemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer (LUTRAERL)
Primary Purpose
Rash
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Minocycline
Clindamycin 2% in hydrocortisone 1% lotion
Erlotinib
Topical clindamycin 2%, triamcinolone acetonide 0.1% soln
Sponsored by
About this trial
This is an interventional treatment trial for Rash focused on measuring Rash, Erlotinib, Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage IIIB or stage IV) non-small cell lung cancer.
- Evidence of disease (measurable disease is not mandatory).
- 18 years of age or older.
- ECOG performance status of 0 - 3.
- Written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
- A history of another cancer other than basal cell carcinoma or cervical cancer in situ within the past 3 years
- Prior therapy with any type of cancer growth factor inhibitor (EGFR inhibitor or agent targeting this family of growth factor receptors)
- Life expectancy of less than 12 weeks.
- Ongoing toxic effects from prior chemotherapy.
- Pregnant or lactating women.
- Females of childbearing potential who have a positive or no pregnancy test (pregnancy tests must be obtained within 72 hours before starting therapy). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Male or female patients with reproductive potential who are unwilling to use effective and reliable contraceptive methods throughout the course of the study and for 90 days after the last dose of study medication.
- Ongoing treatment with any inhibitors or inducers of CYP3A4 activity
- Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
- Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
- Unwilling or unable to comply with the protocol for the duration of the study.
- Patients who have experienced prior hypersensitivity reaction to active ingredients or excipients of the following compounds: erlotinib, minocycline, tetracycline, doxycycline or clindamycin.
Sites / Locations
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BC Cancer Agency - Abbotsford
- Burnaby Hospital Regional Cancer Centre
- BC Cancer Agency - Fraser Valley Centre
- BC Cancer Agency Vancouver Centre
- BC Cancer Agency - Vancouver Island Centre
- Mount Sinai Hospital
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1: Prophylactic Treatment
Arm 2: Reactive Treatment
Arm 3: No Treatment Unless Severe (Grade 3)
Arm Description
Participants will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.
Pts will receive treatment at initiation of rash. Tx is dependent on grading of rash as follows: Grade 1 or 2A: Topical clindamycin 2%, with hydrocortisone 1% in lotion base applied twice daily until resolution of rash by one grade Grade 2B: Topical clindamycin 2%, with hydrocortisone 1% in lotion base applied 2x daily and oral minocycline 100mg 2x daily for a min. of 4 weeks and continuing thereafter, as required, until resolution of rash by 1 grade. Scalp lesions will be treated with a topical clindamycin 2%, triamcinolone acetonide 0.1% soln. Grade 3: Pts will discontinue tx with erlotinib 150mg for 1 week and restart at 100mg once daily. Tx with topical clindamycin 2%, with hydrocortisone 1% in lotion base applied 2x daily and oral minocycline 100mg 2x daily for a min. of 4 weeks and continuing thereafter, as required, until resolution of rash to Grade 1 or 2A. Scalp lesions will be treated with a topical clindamycin 2%, triamcinolone acetonide 0.1% soln.
This is the control group. Patients will be treated only if grade 3 rash develops. For grade 3 rash, treatment will be in accordance with that of Grade 3 rash in Treatment Arm 2.
Outcomes
Primary Outcome Measures
Overall Incidence of Rash
The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.
For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group.
Time Duration From Onset of Rash Until Resolution
To investigate if the rash caused by erlotinib is self-limiting.
A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.
The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.
The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2.
Overall Incidence of Grade 3 Rash
The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.
For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group.
Secondary Outcome Measures
Severity of Rash Caused by Erlotinib
The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash.
Overall Survival
Duration of Treatment
Time to First Presentation of Rash
Full Information
NCT ID
NCT00473083
First Posted
May 10, 2007
Last Updated
February 16, 2017
Sponsor
British Columbia Cancer Agency
Collaborators
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT00473083
Brief Title
Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer
Acronym
LUTRAERL
Official Title
A Randomized Controlled Trial of Systemic and Topical Treatments for Rash Secondary to Erlotinib in Advanced Stage IIIB or IV Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
British Columbia Cancer Agency
Collaborators
Hoffmann-La Roche
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to determine if rash caused by erlotinib can be successfully treated and if so to determine the optimal treatment approach.
Hypothesis:
Hypothesis 1: If the incidence of rash is 50% while on erlotinib, prophylactic monotherapy with minocycline can prevent occurrence in 50% of these patients.
Hypothesis 2: Treatment of rash is successful in improving rash by at least one Grade in 80% of patients.
Hypothesis 3: In patients with untreated rash, the rash will be self-limiting in 25% of patients, and 65% will be grade 1, 2A, and 2b. Ten percent will be grade 3 requiring treatment with monotherapy intervention.
Detailed Description
Erlotinib has been shown to prolong survival in NSCLC patients who are no longer candidates for further chemotherapy. In July 2005, erlotinib was approved in Canada for the treatment of patients with locally advanced or metastatic NSCLC, following failure of first or second-line chemotherapy.
Erlotinib's side effect profile includes rash. The incidence of rash in clinical trials has been reported to be approximately 50 - 75%, and has been hypothesised to parallel tumour response (20).
The treatment of rash is controversial and many oncologists believe it is untreatable and self-limiting. The cause of the rash is not well understood but is felt to be a systemic event. Clinical experience of the investigators has suggested that minocycline 100 mg orally given twice-daily for 4 weeks and clindamycin 2% and hydrocortisone 1% topical cream for moderate to severe rash is a successful treatment.
The objectives of this trial are to better delineate the rash and its features and to describe an optimal treatment. Since the rash is often facial in distribution and can therefore lead to physical and psychological distress to the patient, a dermatology life quality index will also be completed throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rash
Keywords
Rash, Erlotinib, Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Prophylactic Treatment
Arm Type
Experimental
Arm Description
Participants will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.
Arm Title
Arm 2: Reactive Treatment
Arm Type
Experimental
Arm Description
Pts will receive treatment at initiation of rash. Tx is dependent on grading of rash as follows:
Grade 1 or 2A: Topical clindamycin 2%, with hydrocortisone 1% in lotion base applied twice daily until resolution of rash by one grade
Grade 2B: Topical clindamycin 2%, with hydrocortisone 1% in lotion base applied 2x daily and oral minocycline 100mg 2x daily for a min. of 4 weeks and continuing thereafter, as required, until resolution of rash by 1 grade. Scalp lesions will be treated with a topical clindamycin 2%, triamcinolone acetonide 0.1% soln.
Grade 3: Pts will discontinue tx with erlotinib 150mg for 1 week and restart at 100mg once daily.
Tx with topical clindamycin 2%, with hydrocortisone 1% in lotion base applied 2x daily and oral minocycline 100mg 2x daily for a min. of 4 weeks and continuing thereafter, as required, until resolution of rash to Grade 1 or 2A. Scalp lesions will be treated with a topical clindamycin 2%, triamcinolone acetonide 0.1% soln.
Arm Title
Arm 3: No Treatment Unless Severe (Grade 3)
Arm Type
Experimental
Arm Description
This is the control group. Patients will be treated only if grade 3 rash develops. For grade 3 rash, treatment will be in accordance with that of Grade 3 rash in Treatment Arm 2.
Intervention Type
Drug
Intervention Name(s)
Minocycline
Other Intervention Name(s)
Dynacin, Minocin, Minocin PAC, Solodyn, Vectrin, Myrac
Intervention Description
Patients will receive prophylactic treatment with minocycline 100 mg orally twice-daily for at least 4 weeks on the initiation of erlotinib therapy. If rash occurs during the 4 week period of minocycline prophylaxis, the minocycline prophylaxis will continue and additional treatment by grade of rash will be according to the Treatment Arm 2 schedule. If rash occurs after the completion of the 4 week prophylaxis period, treatment by grade of rash will be according to the Treatment Arm 2 schedule.
Intervention Type
Drug
Intervention Name(s)
Clindamycin 2% in hydrocortisone 1% lotion
Intervention Description
Appropriate amounts of clindamycin and hydrocortisone powder are mixed with corresponding amount of Nutraderm® lotion for this mixture.
If preferred, the appropriate amount of clindamycin powder can be mixed with Emo-Cort® lotion (already contains hydrocortisone 1%), available in 60 mL bottles.
Intervention Type
Drug
Intervention Name(s)
Erlotinib
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib will be given on an outpatient basis at a fixed dose of either 150 or 100 mg as a single daily oral dose.
Intervention Type
Drug
Intervention Name(s)
Topical clindamycin 2%, triamcinolone acetonide 0.1% soln
Intervention Description
Clindamycin 2% in Triamcinolone acetonide 0.1% solution in equal parts propylene glycol and water
Primary Outcome Measure Information:
Title
Overall Incidence of Rash
Description
The overall incidence of any grade of erlotinib-induced rash among the three treatment arms.
For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group.
Time Frame
From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year
Title
Time Duration From Onset of Rash Until Resolution
Description
To investigate if the rash caused by erlotinib is self-limiting.
A time variable will be defined to identify the duration from onset of rash until resolution. Resolution will be defined as resolution to severity Grade 1 for patients with rash of maximum severity grade >1 and resolution to Grade 0 for patients with maximum rash severity = 1. For patients where resolution is not observed the time considered will be the maximum time from onset of rash until end of the study.
The analyses will be performed using the following two sub-populations: subjects with maximum severity of rash of Grade 1, 2a and 2b will constitute one sub-population and Grade 3 will be considered the second sub-population.
The comparisons will be performed primarily for Group 1 vs. Group 3 and Group 2 vs. Group 3 and secondly for Group 1 vs. Group 2.
Time Frame
From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year
Title
Overall Incidence of Grade 3 Rash
Description
The overall incidence of grade 3 erlotinib-induced rash among the three treatment arms.
For overall incidence of rash a binary variable will be designed. Data will be summarized with percentages by treatment group.
Time Frame
From onset of rash until resolution, up to 4 weeks following progression, on average of 1 year
Secondary Outcome Measure Information:
Title
Severity of Rash Caused by Erlotinib
Description
The maximum severity of rash per subject will be summarized by treatment group. The summary will include only subjects who indicated any occurrence of rash.
Time Frame
Onset until resolution, up to 4 weeks following progression, on average of 1 year
Title
Overall Survival
Time Frame
Until death
Title
Duration of Treatment
Time Frame
Up to one year
Title
Time to First Presentation of Rash
Time Frame
Up to onset of rash while on study treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically or cytological documented diagnosis of inoperable, locally advanced, recurrent or metastatic (stage IIIB or stage IV) non-small cell lung cancer.
Evidence of disease (measurable disease is not mandatory).
18 years of age or older.
ECOG performance status of 0 - 3.
Written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
Exclusion Criteria:
A history of another cancer other than basal cell carcinoma or cervical cancer in situ within the past 3 years
Prior therapy with any type of cancer growth factor inhibitor (EGFR inhibitor or agent targeting this family of growth factor receptors)
Life expectancy of less than 12 weeks.
Ongoing toxic effects from prior chemotherapy.
Pregnant or lactating women.
Females of childbearing potential who have a positive or no pregnancy test (pregnancy tests must be obtained within 72 hours before starting therapy). (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
Male or female patients with reproductive potential who are unwilling to use effective and reliable contraceptive methods throughout the course of the study and for 90 days after the last dose of study medication.
Ongoing treatment with any inhibitors or inducers of CYP3A4 activity
Any unstable systemic disease (including active infection, grade 4 hypertension, unstable angina, congestive heart failure, hepatic, renal or metabolic disease).
Any significant ophthalmologic abnormality, especially severe dry eye syndrome, keratoconjunctivitis sicca, Sjögren syndrome, severe exposure keratitis or any other disorder likely to increase the risk of corneal epithelial lesions.
Unwilling or unable to comply with the protocol for the duration of the study.
Patients who have experienced prior hypersensitivity reaction to active ingredients or excipients of the following compounds: erlotinib, minocycline, tetracycline, doxycycline or clindamycin.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barb Melosky, MD
Organizational Affiliation
British Columbia Cancer Agency
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
BC Cancer Agency - Abbotsford
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 0C2
Country
Canada
Facility Name
Burnaby Hospital Regional Cancer Centre
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
BC Cancer Agency - Fraser Valley Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V3V 1Z2
Country
Canada
Facility Name
BC Cancer Agency Vancouver Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
BC Cancer Agency - Vancouver Island Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z6
Country
Canada
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Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer
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