A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.
Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT00718315
Collaborator
(none)
201
26
3
38
7.7
0.2
Study Details
Study Description
Brief Summary
This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer.
Study Start Date
:
Apr 1, 2009
Actual Primary Completion Date
:
Jun 1, 2012
Actual Study Completion Date
:
Jun 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: erlotinib [Tarceva]
150mg po daily
Drug: fusidic acid [Verutex]
topical, daily for 30 days.
|
| Experimental: 2
|
Drug: erlotinib [Tarceva]
150mg po daily
Drug: erythromycin [Eritex]
topical, daily for 30 days.
|
| Experimental: 3
|
Drug: erlotinib [Tarceva]
150mg po daily
Drug: Fisiogel
topical, daily for 30 days
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Who Develop Skin Rash [30 Days]
Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash").
- Percentage of Participants With Skin Rash Stratified by Severity Grade [30 Days]
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death
Secondary Outcome Measures
- Time to Appearance of Skin Rash [Days 0, 15, and 30]
Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE
- Percentage of Participants With Erythema [Days 0, 15, and 30]
Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries
- Percentage of Participants With Pruritus [Days 0, 15, and 30]
Pruritus is defined as intense localized itching
- Percentage of Participants With Pain [Days 0, 15, and 30]
Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli
- Percentage of Participants With Erythema Stratified by Severity Grade [30 Days]
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
- Percentage of Participants With Pruritus Stratified by Severity Grade [30 Days]
The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
- Percentage of Participants With Pain Stratified by Severity Grade [30 Days]
The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
adult patients, >=18 years of age;
-
locally advanced or metastatic non-small cell lung cancer (stage IIIB/IV);
-
eligible to start treatment with Tarceva, or receiving Tarceva for <=5 days.
Exclusion Criteria:
-
presence of skin rash or other signs of skin toxicity;
-
treatment with any systemic or intranasal antibiotic within 7 days before randomization;
-
treatment with other topical formulation within 14 days before randomization;
-
other anticancer therapy in addition to Tarceva.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Salvador | BA | Brazil | 40110-150 | |
| 2 | Salvador | BA | Brazil | 40170-110 | |
| 3 | Salvador | BA | Brazil | 41950-610 | |
| 4 | Fortaleza | CE | Brazil | 60125-151 | |
| 5 | Fortaleza | CE | Brazil | 60190-800 | |
| 6 | Taguatinga | DF | Brazil | 72115-700 | |
| 7 | Goiania | GO | Brazil | 74140-050 | |
| 8 | Belo Horizonte | MG | Brazil | 30150-281 | |
| 9 | Belo horizonte | MG | Brazil | 30150-321 | |
| 10 | Divinopolis | MG | Brazil | 35500-222 | |
| 11 | Recife | PE | Brazil | 50070-170 | |
| 12 | Curitiba | PR | Brazil | 80010030 | |
| 13 | Curitiba | PR | Brazil | 80810-050 | |
| 14 | Rio de Janeiro | RJ | Brazil | 22260-020 | |
| 15 | Rio De Janeiro | RJ | Brazil | 22290-160 | |
| 16 | Natal | RN | Brazil | 59040150 | |
| 17 | Ijui | RS | Brazil | 98700-000 | |
| 18 | Porto Alegre | RS | Brazil | 90430-090 | |
| 19 | Itajai | SC | Brazil | 88301-220 | |
| 20 | Ribeirao Preto | SP | Brazil | 14025-270 | |
| 21 | Sao Paulo | SP | Brazil | 01221-020 | |
| 22 | Sao Paulo | SP | Brazil | 01308-000 | |
| 23 | Sao Paulo | SP | Brazil | 01323-000 | |
| 24 | Sao Paulo | SP | Brazil | 01406100 | |
| 25 | Sao Paulo | SP | Brazil | 04039-901 | |
| 26 | Sao Paulo | SP | Brazil | 05652-000 |
Sponsors and Collaborators
- Hoffmann-La Roche
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00718315
Other Study ID Numbers:
- ML21450
First Posted:
Jul 18, 2008
Last Update Posted:
Jan 15, 2015
Last Verified:
Jan 1, 2015
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 milligrams (mg) daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. |
| Period Title: Overall Study | |||
| STARTED | 67 | 67 | 67 |
| COMPLETED | 48 | 45 | 46 |
| NOT COMPLETED | 19 | 22 | 21 |
Baseline Characteristics
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and a thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Total of all reporting groups |
| Overall Participants | 67 | 67 | 67 | 201 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
65.3
(11.1)
|
63.6
(11.0)
|
64.6
(14.0)
|
64.7
(12.2)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
37
55.2%
|
31
46.3%
|
26
38.8%
|
94
46.8%
|
| Male |
30
44.8%
|
36
53.7%
|
41
61.2%
|
107
53.2%
|
Outcome Measures
| Title | Percentage of Participants Who Develop Skin Rash |
|---|---|
| Description | Skin rash was assessed by the investigator and dermatologists (the latter ones only through pictures) and scored according to (National cancer Institute -Common Terminology Criteria for Adverse Events ) NCI-CTCAE ( version 3 (line "Rash/desquamation" - short name "rash"). |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 65 | 65 | 67 |
| Number (95% Confidence Interval) [percentage of participants] |
60.0
89.6%
|
69.2
103.3%
|
73.1
109.1%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.481 |
| Comments | Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test) | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Stiemicyn |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.933 |
| Comments | Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test) | |
| Method | t-test, 1 sided | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.986 |
| Comments | Test for Binomial Ratio, where H0: P >=61%; Ha: P < 61% (One-tailed Test) | |
| Method | t-test, 1 sided | |
| Comments | ||
| Title | Percentage of Participants With Skin Rash Stratified by Severity Grade |
|---|---|
| Description | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 57 | 60 | 60 |
| Grade 0 |
29.8
44.5%
|
25.0
37.3%
|
18.3
27.3%
|
| Grade 1 |
21.1
31.5%
|
18.3
27.3%
|
43.3
64.6%
|
| Grade 2 |
49.1
73.3%
|
56.7
84.6%
|
35.0
52.2%
|
| Grade 3 |
0
0%
|
0
0%
|
3.3
4.9%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
| Grade 5 |
0
0%
|
0
0%
|
0
0%
|
| Title | Time to Appearance of Skin Rash |
|---|---|
| Description | Time to occurence of skin rash was calculated as the number of days from Day 0 until the first appearance of skin rash as defined by NCI-CTCAE |
| Time Frame | Days 0, 15, and 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 65 | 65 | 67 |
| Median (95% Confidence Interval) [Days] |
16.0
|
15.0
|
15.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel, Stiemicyn, Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.095 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Title | Percentage of Participants With Erythema |
|---|---|
| Description | Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries |
| Time Frame | Days 0, 15, and 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 67 | 67 | 67 |
| Number (95% Confidence Interval) [percentage of participants] |
56.7
84.6%
|
56.7
84.6%
|
43.3
64.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel, Stiemicyn, Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.199 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants With Pruritus |
|---|---|
| Description | Pruritus is defined as intense localized itching |
| Time Frame | Days 0, 15, and 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 61 | 63 | 61 |
| Number (95% Confidence Interval) [percentage of participants] |
36.1
53.9%
|
47.6
71%
|
29.5
44%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel, Stiemicyn, Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.108 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants With Pain |
|---|---|
| Description | Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli |
| Time Frame | Days 0, 15, and 30 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 67 | 67 | 67 |
| Number (95% Confidence Interval) [percentage of participants] |
16.4
24.5%
|
25.4
37.9%
|
13.4
20%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel, Stiemicyn, Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.179 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Percentage of Participants With Erythema Stratified by Severity Grade |
|---|---|
| Description | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 61 | 63 | 61 |
| Grade 0 |
37.7
56.3%
|
39.7
59.3%
|
52.5
78.4%
|
| Grade 1 |
39.3
58.7%
|
36.5
54.5%
|
39.3
58.7%
|
| Grade 2 |
23.0
34.3%
|
22.2
33.1%
|
6.6
9.9%
|
| Grade 3 |
0
0%
|
1.6
2.4%
|
1.6
2.4%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
| Grade 5 |
0
0%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel, Stiemicyn, Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.066 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Percentage of Participants With Pruritus Stratified by Severity Grade |
|---|---|
| Description | The severity of skin rash was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 61 | 63 | 61 |
| Grade 0 |
63.9
95.4%
|
52.4
78.2%
|
70.5
105.2%
|
| Grade 1 |
19.7
29.4%
|
31.7
47.3%
|
24.6
36.7%
|
| Grade 2 |
14.8
22.1%
|
14.3
21.3%
|
3.3
4.9%
|
| Grade 3 |
1.6
2.4%
|
1.6
2.4%
|
1.6
2.4%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
| Grade 5 |
0
0%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel, Stiemicyn, Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.087 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Percentage of Participants With Pain Stratified by Severity Grade |
|---|---|
| Description | The severity of pain was graded on a 5 point scale where 0 (equals)= absent, 1= mile, 2=moderate, 3= severe, 4= life threatening and 5= Death; Severity graded by oncologist. |
| Time Frame | 30 Days |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT Population |
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex |
|---|---|---|---|
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days |
| Measure Participants | 61 | 63 | 61 |
| Grade 0 |
82.0
122.4%
|
73.0
109%
|
85.2
127.2%
|
| Grade 1 |
11.5
17.2%
|
22.2
33.1%
|
6.6
9.9%
|
| Grade 2 |
4.9
7.3%
|
4.8
7.2%
|
6.6
9.9%
|
| Grade 3 |
1.6
2.4%
|
0
0%
|
1.6
2.4%
|
| Grade 4 |
0
0%
|
0
0%
|
0
0%
|
| Grade 5 |
0
0%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Fisiogel, Stiemicyn, Verutex |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.308 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Adverse Events
| Time Frame | Adverse Events were recorded from Day 0 to Day 45 (15 days after the End of study) | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Fisiogel | Stiemicyn | Verutex | |||
| Arm/Group Description | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Fisiogel was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Stiemicyn was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days. | Participants received erlotinib 150 mg daily and A thin film of the topical formulation of Verutex was applied to face, neck, and anterior and posterior chest twice daily (every 12 hours), as per medical guidance daily for 30 days | |||
All Cause Mortality |
||||||
| Fisiogel | Stiemicyn | Verutex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Fisiogel | Stiemicyn | Verutex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/67 (17.9%) | 13/66 (19.7%) | 19/67 (28.4%) | |||
| Cardiac disorders | ||||||
| Pericardial effusion (non-malignant) | 1/67 (1.5%) | 0/66 (0%) | 0/67 (0%) | |||
| Gastrointestinal disorders | ||||||
| Ascites (non-malignant) | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Obstruction, GI - small bowel NOS | 1/67 (1.5%) | 0/66 (0%) | 0/67 (0%) | |||
| No specification | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Vomiting | 0/67 (0%) | 1/66 (1.5%) | 0/67 (0%) | |||
| Hemorrhage, GI, lower GI NOS | 1/67 (1.5%) | 0/66 (0%) | 0/67 (0%) | |||
| Hemorrhage, GI, stomach | 0/67 (0%) | 1/66 (1.5%) | 0/67 (0%) | |||
| General disorders | ||||||
| Fatigue (asthenia, lethargy, malaise | 0/67 (0%) | 2/66 (3%) | 1/67 (1.5%) | |||
| Fever (in the absence of neutropenia, where neurtropenia is defined as ANC <1.0x109/L) | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| No specification | 0/67 (0%) | 1/66 (1.5%) | 0/67 (0%) | |||
| Infections and infestations | ||||||
| Sepsis | 0/67 (0%) | 1/66 (1.5%) | 0/67 (0%) | |||
| Lung (pneumonia) | 1/67 (1.5%) | 1/66 (1.5%) | 1/67 (1.5%) | |||
| Pulmonary/upper respiratory | 0/67 (0%) | 0/66 (0%) | 3/67 (4.5%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Death not associated with CTCAE term | 2/67 (3%) | 3/66 (4.5%) | 2/67 (3%) | |||
| Death not associated with CTCAE term - "cardiac arrest" | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Disease progression NOS | 1/67 (1.5%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Nervous system disorders | ||||||
| CNS cerebrovascular ischemia | 1/67 (1.5%) | 0/66 (0%) | 0/67 (0%) | |||
| Confusion | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Renal and urinary disorders | ||||||
| Renal failure | 1/67 (1.5%) | 0/66 (0%) | 0/67 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Hemorrhage, pulmonary/upper respiratory, bronchopulmonary NOS | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Hemorrhage, pulmonary/upper respiratory, respiratory tract NOS | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| No specification, pulmonary/upper respiratory, pain | 0/67 (0%) | 1/66 (1.5%) | 1/67 (1.5%) | |||
| Adult respiratory distress syndrome | 0/67 (0%) | 2/66 (3%) | 2/67 (3%) | |||
| Dyspnea (shortness of breath) | 3/67 (4.5%) | 2/66 (3%) | 4/67 (6%) | |||
| Pleural effusion (non-malignant) | 2/67 (3%) | 0/66 (0%) | 1/67 (1.5%) | |||
| No specification | 0/67 (0%) | 1/66 (1.5%) | 3/67 (4.5%) | |||
| Vascular disorders | ||||||
| No specification, cardiovascular, pain | 0/67 (0%) | 1/66 (1.5%) | 0/67 (0%) | |||
| Thrombosis/thrombus/embolism | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Vessel injury - vein - SVC | 0/67 (0%) | 0/66 (0%) | 1/67 (1.5%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Fisiogel | Stiemicyn | Verutex | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/67 (67.2%) | 45/66 (68.2%) | 48/67 (71.6%) | |||
| Blood and lymphatic system disorders | ||||||
| Hemoglobin | 0/67 (0%) | 2/66 (3%) | 2/67 (3%) | |||
| Eye disorders | ||||||
| Dry eye syndrome | 2/67 (3%) | 0/66 (0%) | 1/67 (1.5%) | |||
| Gastrointestinal disorders | ||||||
| Diarrhea | 15/67 (22.4%) | 18/66 (27.3%) | 14/67 (20.9%) | |||
| Anorexia | 5/67 (7.5%) | 7/66 (10.6%) | 6/67 (9%) | |||
| Nausea | 3/67 (4.5%) | 4/66 (6.1%) | 3/67 (4.5%) | |||
| Mucositis/stomatitis (clinical exam) - oral cavity | 2/67 (3%) | 5/66 (7.6%) | 2/67 (3%) | |||
| Vomiting | 2/67 (3%) | 4/66 (6.1%) | 0/67 (0%) | |||
| Constipation | 1/67 (1.5%) | 2/66 (3%) | 2/67 (3%) | |||
| Mucositis/stomatitis (functional/symptomatic) - oral cavity | 2/67 (3%) | 1/66 (1.5%) | 1/67 (1.5%) | |||
| No specification | 0/67 (0%) | 1/66 (1.5%) | 3/67 (4.5%) | |||
| Dry mouth/salivary gland (xerostomia) | 1/67 (1.5%) | 2/66 (3%) | 0/67 (0%) | |||
| No specification | 2/67 (3%) | 1/66 (1.5%) | 1/67 (1.5%) | |||
| General disorders | ||||||
| Fatigue (asthenia, lethargy, malaise) | 9/67 (13.4%) | 8/66 (12.1%) | 4/67 (6%) | |||
| Fever | 2/67 (3%) | 1/66 (1.5%) | 2/67 (3%) | |||
| No specification | 3/67 (4.5%) | 1/66 (1.5%) | 2/67 (3%) | |||
| Infections and infestations | ||||||
| Lung (pneumonia) | 1/67 (1.5%) | 1/66 (1.5%) | 1/67 (1.5%) | |||
| Pulmonary/upper respiratory | 1/67 (1.5%) | 4/66 (6.1%) | 6/67 (9%) | |||
| Renal/genitourinary | 1/67 (1.5%) | 0/66 (0%) | 3/67 (4.5%) | |||
| No specification | 1/67 (1.5%) | 1/66 (1.5%) | 2/67 (3%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| No specification | 1/67 (1.5%) | 4/66 (6.1%) | 1/67 (1.5%) | |||
| No specification | 1/67 (1.5%) | 1/66 (1.5%) | 1/67 (1.5%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Death not associated with CTCAE term | 2/67 (3%) | 3/66 (4.5%) | 2/67 (3%) | |||
| Nervous system disorders | ||||||
| Dizziness | 1/67 (1.5%) | 2/66 (3%) | 2/67 (3%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea (shortness of breath) | 6/67 (9%) | 4/66 (6.1%) | 4/67 (6%) | |||
| Cough | 3/67 (4.5%) | 7/66 (10.6%) | 0/67 (0%) | |||
| No specification | 2/67 (3%) | 1/66 (1.5%) | 4/67 (6%) | |||
| Adult respiratory distress syndrome | 0/67 (0%) | 2/66 (3%) | 2/67 (3%) | |||
| Pleural effusion (non-malignant) | 2/67 (3%) | 0/66 (0%) | 1/67 (1.5%) | |||
| No specification | 0/67 (0%) | 2/66 (3%) | 2/67 (3%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| No specification | 2/67 (3%) | 1/66 (1.5%) | 4/67 (6%) | |||
| Dry skin | 1/67 (1.5%) | 2/66 (3%) | 3/67 (4.5%) | |||
| Nail change | 0/67 (0%) | 3/66 (4.5%) | 0/67 (0%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The study being conducted under this agreement is part of the overall study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the study, but after the first publication or presentation that involves the overall study. Sponsor may request that confidential information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
| Name/Title | Medical Communications |
|---|---|
| Organization | Hoffmann- LaRoche |
| Phone | 1-800-821-8590 |
| genentech@druginfo.com |
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00718315
Other Study ID Numbers:
- ML21450
First Posted:
Jul 18, 2008
Last Update Posted:
Jan 15, 2015
Last Verified:
Jan 1, 2015