Non-Small Cell Lung Cancer
Conditions
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.
Interventions
DRUGerlotinib [Tarceva]
150mg po daily
DRUGfusidic acid [Verutex]
topical, daily for 30 days.
DRUGerythromycin [Eritex]
topical, daily for 30 days.
DRUGFisiogel
topical, daily for 30 days
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fisiogel 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. | 67 |
| Stiemicyn 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. | 67 |
| Verutex 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. | 67 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 3 |
| Overall Study | Death | 6 | 6 | 5 |
| Overall Study | Disease progression | 0 | 1 | 1 |
| Overall Study | Erlotinib dose decreased | 4 | 3 | 1 |
| Overall Study | Lost to Follow-up | 2 | 3 | 4 |
| Overall Study | Other | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 5 | 5 | 3 |
| Overall Study | Use of ATB and Corticoids | 0 | 1 | 2 |
| Overall Study | Use of Minocyclin | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Fisiogel | Stiemicyn | Verutex | Total |
|---|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 11.1 | 63.6 years STANDARD_DEVIATION 11 | 64.6 years STANDARD_DEVIATION 14 | 64.7 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 37 Participants | 31 Participants | 26 Participants | 94 Participants |
| Sex: Female, Male Male | 30 Participants | 36 Participants | 41 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 45 / 67 | 45 / 66 | 48 / 67 |
| serious Total, serious adverse events | 12 / 67 | 13 / 66 | 19 / 67 |
Outcome results
Primary
Percentage of Participants Who Develop Skin Rash
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
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fisiogel | Percentage of Participants Who Develop Skin Rash | 60.0 percentage of participants |
| Stiemicyn | Percentage of Participants Who Develop Skin Rash | 69.2 percentage of participants |
| Verutex | Percentage of Participants Who Develop Skin Rash | 73.1 percentage of participants |
p-value: 0.481t-test, 1 sided
p-value: 0.933t-test, 1 sided
p-value: 0.986t-test, 1 sided
Primary
Percentage of Participants With Skin Rash Stratified by Severity Grade
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
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fisiogel | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 0 | 29.8 percentage of participants |
| Fisiogel | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Fisiogel | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 2 | 49.1 percentage of participants |
| Fisiogel | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 1 | 21.1 percentage of participants |
| Fisiogel | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 3 | 0 percentage of participants |
| Fisiogel | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 3 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 0 | 25.0 percentage of participants |
| Stiemicyn | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 1 | 18.3 percentage of participants |
| Stiemicyn | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 2 | 56.7 percentage of participants |
| Verutex | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Verutex | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 0 | 18.3 percentage of participants |
| Verutex | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 2 | 35.0 percentage of participants |
| Verutex | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 3 | 3.3 percentage of participants |
| Verutex | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Verutex | Percentage of Participants With Skin Rash Stratified by Severity Grade | Grade 1 | 43.3 percentage of participants |
Secondary
Percentage of Participants With Erythema
Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries
Time frame: Days 0, 15, and 30
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fisiogel | Percentage of Participants With Erythema | 56.7 percentage of participants |
| Stiemicyn | Percentage of Participants With Erythema | 56.7 percentage of participants |
| Verutex | Percentage of Participants With Erythema | 43.3 percentage of participants |
p-value: 0.199Chi-squared
Secondary
Percentage of Participants With Erythema Stratified by Severity Grade
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
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fisiogel | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Fisiogel | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Fisiogel | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 2 | 23.0 percentage of participants |
| Fisiogel | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 0 | 37.7 percentage of participants |
| Fisiogel | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 1 | 39.3 percentage of participants |
| Fisiogel | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 3 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 1 | 36.5 percentage of participants |
| Stiemicyn | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 3 | 1.6 percentage of participants |
| Stiemicyn | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 0 | 39.7 percentage of participants |
| Stiemicyn | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 2 | 22.2 percentage of participants |
| Verutex | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Verutex | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Verutex | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 0 | 52.5 percentage of participants |
| Verutex | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 2 | 6.6 percentage of participants |
| Verutex | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 3 | 1.6 percentage of participants |
| Verutex | Percentage of Participants With Erythema Stratified by Severity Grade | Grade 1 | 39.3 percentage of participants |
p-value: 0.066Kruskal-Wallis
Secondary
Percentage of Participants With Pain
Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli
Time frame: Days 0, 15, and 30
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fisiogel | Percentage of Participants With Pain | 16.4 percentage of participants |
| Stiemicyn | Percentage of Participants With Pain | 25.4 percentage of participants |
| Verutex | Percentage of Participants With Pain | 13.4 percentage of participants |
p-value: 0.179Chi-squared
Secondary
Percentage of Participants With Pain Stratified by Severity Grade
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
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fisiogel | Percentage of Participants With Pain Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Fisiogel | Percentage of Participants With Pain Stratified by Severity Grade | Grade 0 | 82.0 percentage of participants |
| Fisiogel | Percentage of Participants With Pain Stratified by Severity Grade | Grade 1 | 11.5 percentage of participants |
| Fisiogel | Percentage of Participants With Pain Stratified by Severity Grade | Grade 2 | 4.9 percentage of participants |
| Fisiogel | Percentage of Participants With Pain Stratified by Severity Grade | Grade 3 | 1.6 percentage of participants |
| Fisiogel | Percentage of Participants With Pain Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pain Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pain Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pain Stratified by Severity Grade | Grade 2 | 4.8 percentage of participants |
| Stiemicyn | Percentage of Participants With Pain Stratified by Severity Grade | Grade 3 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pain Stratified by Severity Grade | Grade 0 | 73.0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pain Stratified by Severity Grade | Grade 1 | 22.2 percentage of participants |
| Verutex | Percentage of Participants With Pain Stratified by Severity Grade | Grade 0 | 85.2 percentage of participants |
| Verutex | Percentage of Participants With Pain Stratified by Severity Grade | Grade 1 | 6.6 percentage of participants |
| Verutex | Percentage of Participants With Pain Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Verutex | Percentage of Participants With Pain Stratified by Severity Grade | Grade 2 | 6.6 percentage of participants |
| Verutex | Percentage of Participants With Pain Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Verutex | Percentage of Participants With Pain Stratified by Severity Grade | Grade 3 | 1.6 percentage of participants |
p-value: 0.308Kruskal-Wallis
Secondary
Percentage of Participants With Pruritus
Pruritus is defined as intense localized itching
Time frame: Days 0, 15, and 30
Population: ITT Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fisiogel | Percentage of Participants With Pruritus | 36.1 percentage of participants |
| Stiemicyn | Percentage of Participants With Pruritus | 47.6 percentage of participants |
| Verutex | Percentage of Participants With Pruritus | 29.5 percentage of participants |
p-value: 0.108Chi-squared
Secondary
Percentage of Participants With Pruritus Stratified by Severity Grade
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
Population: ITT Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fisiogel | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 1 | 19.7 percentage of participants |
| Fisiogel | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 0 | 63.9 percentage of participants |
| Fisiogel | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 2 | 14.8 percentage of participants |
| Fisiogel | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 3 | 1.6 percentage of participants |
| Fisiogel | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Fisiogel | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 1 | 31.7 percentage of participants |
| Stiemicyn | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 3 | 1.6 percentage of participants |
| Stiemicyn | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
| Stiemicyn | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 0 | 52.4 percentage of participants |
| Stiemicyn | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 2 | 14.3 percentage of participants |
| Verutex | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 0 | 70.5 percentage of participants |
| Verutex | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 2 | 3.3 percentage of participants |
| Verutex | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 5 | 0 percentage of participants |
| Verutex | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 3 | 1.6 percentage of participants |
| Verutex | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 1 | 24.6 percentage of participants |
| Verutex | Percentage of Participants With Pruritus Stratified by Severity Grade | Grade 4 | 0 percentage of participants |
p-value: 0.087Kruskal-Wallis
Secondary
Time to Appearance of Skin Rash
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
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Fisiogel | Time to Appearance of Skin Rash | 16.0 Days |
| Stiemicyn | Time to Appearance of Skin Rash | 15.0 Days |
| Verutex | Time to Appearance of Skin Rash | 15.0 Days |
p-value: 0.095Log Rank