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Non-Small Cell Lung CancerPhase 3NCT00718315

A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

A Phase 3 study testing erlotinib [Tarceva], fusidic acid [Verutex] and erythromycin [Eritex] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 26 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-Small Cell Lung Cancer
What is being tested?
erlotinib [Tarceva], fusidic acid [Verutex] and erythromycin [Eritex]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
26 sitesBrazil
Study dates
Apr 2009to Jun 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Brazil26 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-281

  • Study site

    Belo Horizonte, Minas Gerais, 30150-321

  • Study site

    Curitiba, Paraná, 80010030

  • Study site

    Curitiba, Paraná, 80810-050

  • Study site

    Divinópolis, Minas Gerais, 35500-222

  • Study site

    Fortaleza, Ceará, 60125-151

  • Study site

    Fortaleza, Ceará, 60190-800

  • Study site

    Goiânia, Goiás, 74140-050

  • Study site

    Ijuí, Rio Grande do Sul, 98700-000

  • Study site

    Itajaí, Santa Catarina, 88301-220

  • Study site

    Natal, Rio Grande do Norte, 59040150

  • Study site

    Porto Alegre, Rio Grande do Sul, 90430-090

  • Study site

    Recife, Pernambuco, 50070-170

  • Study site

    Ribeirão Preto, São Paulo, 14025-270

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22260-020

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22290-160

  • Study site

    Salvador, Estado de Bahia, 40110-150

  • Study site

    Salvador, Estado de Bahia, 40170-110

  • Study site

    Salvador, Estado de Bahia, 41950-610

  • Study site

    São Paulo, São Paulo, 01221-020

  • Study site

    São Paulo, São Paulo, 01308-000

  • Study site

    São Paulo, São Paulo, 01323-000

  • Study site

    São Paulo, São Paulo, 01406100

  • Study site

    São Paulo, São Paulo, 04039-901

  • Study site

    São Paulo, São Paulo, 05652-000

  • Study site

    Taguatinga, Federal District, 72115-700

Other trials in Brazil

About this study

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.

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.

Being tested
erlotinib [Tarceva], fusidic acid [Verutex], erythromycin [Eritex], Fisiogel
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • erlotinib [Tarceva]Drug

    150mg po daily

  • fusidic acid [Verutex]Drug

    topical, daily for 30 days.

  • erythromycin [Eritex]Drug

    topical, daily for 30 days.

  • FisiogelDrug

    topical, daily for 30 days

Study groups in NCT00718315
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: erlotinib [Tarceva]; Drug: fusidic acid [Verutex]
2ExperimentalNot described
Receives: Drug: erlotinib [Tarceva]; Drug: erythromycin [Eritex]
3ExperimentalNot described
Receives: Drug: erlotinib [Tarceva]; Drug: Fisiogel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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").

    Measured: 30 Days

  2. 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

    Measured: 30 Days

Secondary outcomes (7)

  1. 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

    Measured: Days 0, 15, and 30

  2. Percentage of Participants With Erythema

    Erythema is defined as redness of the skin or mucous membranes, caused by hyperemia of superficial capillaries

    Measured: Days 0, 15, and 30

  3. Percentage of Participants With Pruritus

    Pruritus is defined as intense localized itching

    Measured: Days 0, 15, and 30

  4. Percentage of Participants With Pain

    Pain is defined as an unpleasant feeling often caused by intense or damaging stimuli

    Measured: Days 0, 15, and 30

  5. 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.

    Measured: 30 Days

  6. 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.

    Measured: 30 Days

  7. 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.

    Measured: 30 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2008 (estimated)
  2. Study startApr 2009
  3. Primary completionJun 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00718315
Sponsor's protocol ID
ML21450
Status last verified
Jan 2015
First submitted
16 Jul 2008
Last updated
15 Jan 2015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing erlotinib [Tarceva], fusidic acid [Verutex] and erythromycin [Eritex] in people with Non-Small Cell Lung Cancer, run by Hoffmann-La Roche at 26 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Develop Skin Rash (time frame: 30 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00718315.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2015.

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