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Trial record 29 of 115 for:    cancer | butyrate

Systemic and Topical Treatments for Rash Secondary to Erlotinib in Lung Cancer (LUTRAERL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00473083
Recruitment Status : Completed
First Posted : May 14, 2007
Results First Posted : April 4, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
British Columbia Cancer Agency

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rash
Interventions Drug: Minocycline
Drug: Clindamycin 2% in hydrocortisone 1% lotion
Drug: Erlotinib
Drug: Topical clindamycin 2%, triamcinolone acetonide 0.1% soln
Enrollment 150
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description

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: 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: 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.

Period Title: Overall Study
Started 50 50 50
Completed 49 [1] 50 50
Not Completed 1 0 0
Reason Not Completed
Adverse Event             1             0             0
[1]
One patient (2%) from treatment arm 1 discontinued the study drug as a result of a TEAE (dizziness)
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatmen Arm 3: No Treatment Unless Severe (Grade 3) Total
Hide Arm/Group Description

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: 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: 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 of all reporting groups
Overall Number of Baseline Participants 50 50 50 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 50 participants 150 participants
64.3
(30 to 79)
65.9
(48 to 83)
64.4
(46 to 82)
64.9
(30 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 50 participants 150 participants
Female
17
  34.0%
27
  54.0%
27
  54.0%
71
  47.3%
Male
33
  66.0%
23
  46.0%
23
  46.0%
79
  52.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 50 participants 50 participants 50 participants 150 participants
50 50 50 150
1.Primary Outcome
Title Overall Incidence of Rash
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description:

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: 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: 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 Number of Participants Analyzed 50 50 50
Measure Type: Number
Unit of Measure: percentage of participants
84 84 82
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8769
Comments P for arm 1 v arms 2 and 3 combined
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.147
Comments P for arm 1 v arms 2 and 3 combined
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Time Duration From Onset of Rash Until Resolution
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description

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)

Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description:

Subjects 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 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: Subjects 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 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: Subjects 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 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 Number of Participants Analyzed 42 42 41
Median (Inter-Quartile Range)
Unit of Measure: days
Patients With Max Severity of Rash Gr 1, 2a and 2b Number Analyzed 36 participants 38 participants 27 participants
133.0
(80.5 to 308.5)
92.0
(51.0 to 301.0)
98.0
(47.0 to 143.0)
Patients With Maximum Severity of Rash Grade 3 Number Analyzed 6 participants 4 participants 14 participants
201.0
(77.0 to 449.0)
76.0
(56.5 to 90.5)
54.0
(50.0 to 158.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1503
Comments P(arm 1 v arm 2) in patients with maximum severity of rash grade 1, 2a, or 2b
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4681
Comments P(arm2 v arm3) in patients with maximum severity of rash grade 1, 2a, or 2b
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0196
Comments P(arm 1 v arm 3) in patients with maximum severity of rash grade 1, 2a, or 2b
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1658
Comments P(arm 1 v arm 2) in patients with maximum severity of rash grade 3
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.9999
Comments

P(arm 2 v arm 3) in patients with maximum severity of rash grade 3.

P-value was calculated to be >0.9999 using the Wilcoxon Rank Sumtest by comparing between the two treatment arms.

Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.285
Comments P(arm 1 v arm 3) in patients with maximum severity of rash grade 3
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Primary Outcome
Title Overall Incidence of Grade 3 Rash
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description:

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: 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: 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 Number of Participants Analyzed 50 50 50
Measure Type: Number
Unit of Measure: percentage of participants
14.3 9.5 34.1
4.Secondary Outcome
Title Severity of Rash Caused by Erlotinib
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Arm 1 (n=42), Arm 2 (n=42), Arm 3, (n=41)
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description:

Subjects 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 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: Subjects 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 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: Subjects 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 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 Number of Participants Analyzed 42 42 41
Measure Type: Number
Unit of Measure: percentage of participants
Maximal Rash Grade 1 40.5 47.6 46.3
Maximal Rash Grade 2a 26.2 33.3 14.6
Maximal Rash Grade 2b 19.0 9.5 4.9
Maximal Rash Grade 3 14.3 9.5 34.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment
Comments Maximal Rash Grade 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5097
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment
Comments Maximal Rash Grade 2a
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4740
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment
Comments Maximal Severity Grade 2b
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2123
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment
Comments Maximal Severity Grade 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5004
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9072
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 2a
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0464
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 2b
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6759
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0065
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 1
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5898
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 2a
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1921
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 2b
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0882
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments Maximal Severity Grade 3
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0344
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame Until death
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description:

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: 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: 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 Number of Participants Analyzed 50 50 50
Median (95% Confidence Interval)
Unit of Measure: months
7.6
(4.7 to 12.4)
8.0
(3.5 to 11.8)
6.0
(5.5 to 7.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3834
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Duration of Treatment
Hide Description [Not Specified]
Time Frame Up to one year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description:

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: 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: 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 Number of Participants Analyzed 50 50 50
Median (95% Confidence Interval)
Unit of Measure: months
3.6
(2.1 to 4.6)
1.8
(1.3 to 2.7)
1.8
(1.7 to 2.4)
7.Secondary Outcome
Title Time to First Presentation of Rash
Hide Description [Not Specified]
Time Frame Up to onset of rash while on study treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with maximum severity of rash of grade 1, 2a, 2b and 3
Arm/Group Title Arm 1: Prophylactic Treatment Arm 2: Reactive Treatment Arm 3: No Treatment Unless Severe (Grade 3)
Hide Arm/Group Description:

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: 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: 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 Number of Participants Analyzed 42 42 41
Mean (Standard Deviation)
Unit of Measure: days
17.4  (19.7) 13.3  (19.0) 12.0  (11.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: Prophylactic Treatment, Arm 2: Reactive Treatment, Arm 3: No Treatment Unless Severe (Grade 3)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0147
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm 1: Rash Prevention Arm 2: Treat Only Upon Initiation of Rash Arm 3: Treat Only if Grade 3 Rash Occurs
Hide Arm/Group Description

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: 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: 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.

All-Cause Mortality
Arm 1: Rash Prevention Arm 2: Treat Only Upon Initiation of Rash Arm 3: Treat Only if Grade 3 Rash Occurs
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm 1: Rash Prevention Arm 2: Treat Only Upon Initiation of Rash Arm 3: Treat Only if Grade 3 Rash Occurs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/49 (2.04%)      0/50 (0.00%)      0/50 (0.00%)    
Endocrine disorders       
Pancreatitis 1 [1]  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
1
Term from vocabulary, MedDRA (11.0)
[1]
From treatment arm 1, however this SAE did not lead to discontinuation of treatment.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: Rash Prevention Arm 2: Treat Only Upon Initiation of Rash Arm 3: Treat Only if Grade 3 Rash Occurs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/49 (24.49%)      1/50 (2.00%)      5/50 (10.00%)    
Endocrine disorders       
Pancreatitis  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
Gastrointestinal disorders       
Diarrhea  2/49 (4.08%)  2 0/50 (0.00%)  0 0/50 (0.00%)  0
Dyspepsia  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
General disorders       
Gastroesophageal reflux disease  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
Nausea  5/49 (10.20%)  5 0/50 (0.00%)  0 1/50 (2.00%)  1
Fatigue  2/49 (4.08%)  2 0/50 (0.00%)  0 0/50 (0.00%)  0
Decreased appetite  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
Dizziness  2/49 (4.08%)  2 0/50 (0.00%)  0 2/50 (4.00%)  2
Dysgeusia  1/49 (2.04%)  1 0/50 (0.00%)  0 1/50 (2.00%)  1
Headache  0/49 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1
Chromaturia  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
Dry Skin  0/49 (0.00%)  0 1/50 (2.00%)  1 0/50 (0.00%)  0
Skin Pain  0/49 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1
Blister  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
Hepatobiliary disorders       
Hyperbilirubinemia  0/49 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1
Immune system disorders       
Rash  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
Metabolism and nutrition disorders       
Anorexia  1/49 (2.04%)  1 0/50 (0.00%)  0 0/50 (0.00%)  0
Nervous system disorders       
Parsomia  0/49 (0.00%)  0 0/50 (0.00%)  0 1/50 (2.00%)  1
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Barbara Melosky, Principal Investigator
Organization: BC Cancer Agency
Phone: 604-877-6000
EMail: BMelosky@bccancer.bc.ca
Other Publications:
IMPATH Inc. Analysis of EGFr Expression in a selection of tumour types. IMPATH Study Number PFZ04. 1998-1999:1-16.
Ohsaki Y, Toyoshima E, Fujiuchi S, Nishigaki Y, Kikuchi K. EGR receptor (EGFR) expression correlates poor prognosis in non-small cell lung cancer (NSCLC) patients interacting with p53 overexpression (abstract). Proc Am Assoc Cancer Res 1997; 38:327.
Layout table for additonal information
Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00473083     History of Changes
Other Study ID Numbers: ML21016
First Submitted: May 10, 2007
First Posted: May 14, 2007
Results First Submitted: January 22, 2016
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017