Trial Outcomes & Findings for Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer (NCT NCT00473083)
NCT ID: NCT00473083
Last Updated: 2017-04-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
From onset of rash until resolution, up to 4 weeks following progression, an average of 1 year
Results posted on
2017-04-04
Participant Flow
Eligible patients had a histological or cytologic documented diagnosis of metastatic NSCLC, with and Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3. The study was initiated on November 7, 2008, and concluded with the last patient in December 2012.
Participant milestones
| Measure |
Arm 1: Prophylactic Treatment
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
49
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: Prophylactic Treatment
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: Prophylactic Treatment
n=50 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatmen
n=50 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=50 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.3 years
n=99 Participants
|
65.9 years
n=107 Participants
|
64.4 years
n=206 Participants
|
64.9 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
27 Participants
n=206 Participants
|
71 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
79 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
50 participants
n=206 Participants
|
150 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 yearThe 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.
Outcome measures
| Measure |
Arm 1: Prophylactic Treatment
n=50 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
n=50 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=50 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Overall Incidence of Rash
|
84 percentage of participants
|
84 percentage of participants
|
82 percentage of participants
|
PRIMARY outcome
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, an average of 1 yearPopulation: Patients With Maximum Severity of Rash Grade 1, 2b: Arm 1 (n=36), Arm 2 (n=38), Arm 3 (n=27) Patients With Maximum Severity of Rash Grade 3: Arm 1 (n=6), Arm 2 (n=4), Arm 3 (n=14)
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.
Outcome measures
| Measure |
Arm 1: Prophylactic Treatment
n=42 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
n=42 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=41 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Time Duration From Onset of Rash Until Resolution
Patients With Max Severity of Rash Gr 1, 2a and 2b
|
133.0 days
Interval 80.5 to 308.5
|
92.0 days
Interval 51.0 to 301.0
|
98.0 days
Interval 47.0 to 143.0
|
|
Time Duration From Onset of Rash Until Resolution
Patients With Maximum Severity of Rash Grade 3
|
201.0 days
Interval 77.0 to 449.0
|
76.0 days
Interval 56.5 to 90.5
|
54.0 days
Interval 50.0 to 158.0
|
PRIMARY outcome
Timeframe: From onset of rash until resolution, up to 4 weeks following progression, on average of 1 yearThe 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.
Outcome measures
| Measure |
Arm 1: Prophylactic Treatment
n=50 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
n=50 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=50 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Overall Incidence of Grade 3 Rash
|
14.3 percentage of participants
|
9.5 percentage of participants
|
34.1 percentage of participants
|
SECONDARY outcome
Timeframe: Onset until resolution, up to 4 weeks following progression, on average of 1 yearPopulation: Arm 1 (n=42), Arm 2 (n=42), Arm 3, (n=41)
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.
Outcome measures
| Measure |
Arm 1: Prophylactic Treatment
n=42 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
n=42 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=41 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Severity of Rash Caused by Erlotinib
Maximal Rash Grade 1
|
40.5 percentage of participants
|
47.6 percentage of participants
|
46.3 percentage of participants
|
|
Severity of Rash Caused by Erlotinib
Maximal Rash Grade 2a
|
26.2 percentage of participants
|
33.3 percentage of participants
|
14.6 percentage of participants
|
|
Severity of Rash Caused by Erlotinib
Maximal Rash Grade 2b
|
19.0 percentage of participants
|
9.5 percentage of participants
|
4.9 percentage of participants
|
|
Severity of Rash Caused by Erlotinib
Maximal Rash Grade 3
|
14.3 percentage of participants
|
9.5 percentage of participants
|
34.1 percentage of participants
|
SECONDARY outcome
Timeframe: Until deathOutcome measures
| Measure |
Arm 1: Prophylactic Treatment
n=50 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
n=50 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=50 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Overall Survival
|
7.6 months
Interval 4.7 to 12.4
|
8.0 months
Interval 3.5 to 11.8
|
6.0 months
Interval 5.5 to 7.3
|
SECONDARY outcome
Timeframe: Up to one yearOutcome measures
| Measure |
Arm 1: Prophylactic Treatment
n=50 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
n=50 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=50 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Duration of Treatment
|
3.6 months
Interval 2.1 to 4.6
|
1.8 months
Interval 1.3 to 2.7
|
1.8 months
Interval 1.7 to 2.4
|
SECONDARY outcome
Timeframe: Up to onset of rash while on study treatmentPopulation: Subjects with maximum severity of rash of grade 1, 2a, 2b and 3
Outcome measures
| Measure |
Arm 1: Prophylactic Treatment
n=42 Participants
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Reactive Treatment
n=42 Participants
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: No Treatment Unless Severe (Grade 3)
n=41 Participants
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Time to First Presentation of Rash
|
17.4 days
Standard Deviation 19.7
|
13.3 days
Standard Deviation 19.0
|
12.0 days
Standard Deviation 11.1
|
Adverse Events
Arm 1: Rash Prevention
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2: Treat Only Upon Initiation of Rash
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 3: Treat Only if Grade 3 Rash Occurs
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: Rash Prevention
n=49 participants at risk
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Treat Only Upon Initiation of Rash
n=50 participants at risk
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: Treat Only if Grade 3 Rash Occurs
n=50 participants at risk
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Endocrine disorders
Pancreatitis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
Other adverse events
| Measure |
Arm 1: Rash Prevention
n=49 participants at risk
Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented
minocycline: Arm 1: Subjects (approximately 50) will be given minocycline (an antibiotic pill) 100mg orally to take for 4 weeks at the same time as starting their erlotinib to see if the rash can be prevented. If rash occurs then subjects will be treated using a medicated lotion, (clindamycin 2% and hydrocortisone 1%,) to be applied to the rash and if the rash is more severe, minocycline may be continued for more than 4 weeks.
|
Arm 2: Treat Only Upon Initiation of Rash
n=50 participants at risk
Arm 2: Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
minocycline; Lotion (clindamycin 2% /hydrocortisone 1%): Subjects (Approximately 50) will be treated for the rash caused by erlotinib when it develops and the treatment will be a medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and if the rash is more severe, minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
|
Arm 3: Treat Only if Grade 3 Rash Occurs
n=50 participants at risk
Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution
clindamycin 2% and hydrocortisone 1%,: Arm 3: Subjects (Approximately 50) that develop the rash caused by erlotinib will only be treated if their rash becomes severe to see if it will go away itself. The treatment for severe rash will be medicated lotion, (clindamycin 2% and hydrocortisone 1%,), applied to the rash and minocycline 100mg orally twice daily. Scalp lesions will be treated with a topical clindamycin 2 %, triamcinolone acetonide 0.1% solution.
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
4.1%
2/49 • Number of events 2
|
0.00%
0/50
|
0.00%
0/50
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Gastroesophageal reflux disease
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Nausea
|
10.2%
5/49 • Number of events 5
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Fatigue
|
4.1%
2/49 • Number of events 2
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Decreased appetite
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Dizziness
|
4.1%
2/49 • Number of events 2
|
0.00%
0/50
|
4.0%
2/50 • Number of events 2
|
|
Endocrine disorders
Pancreatitis
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/49
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Dysgeusia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Headache
|
0.00%
0/49
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Parsomia
|
0.00%
0/49
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Chromaturia
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
|
General disorders
Dry Skin
|
0.00%
0/49
|
2.0%
1/50 • Number of events 1
|
0.00%
0/50
|
|
General disorders
Skin Pain
|
0.00%
0/49
|
0.00%
0/50
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Blister
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
|
Immune system disorders
Rash
|
2.0%
1/49 • Number of events 1
|
0.00%
0/50
|
0.00%
0/50
|
Additional Information
Dr. Barbara Melosky, Principal Investigator
BC Cancer Agency
Phone: 604-877-6000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place