Skin RashNCT00709878
Histological Characterization and Differentiation of Rash From Other Epidermal Growth Factor Receptor (EGFR) Inhibitors
An observational study of Skin Rash, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to characterize the microscopic findings of skin rash associated with the use of chemotherapeutic anticancer agents known as epidermal growth factor inhibitors (EGFRIs). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Skin Rash
- What is being tested?
- Skin Biopsy of Skin Rash Secondary to EGFRI Use
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Aug 2010
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients selected for this study were treated with lapatinib, erlotinib, panitumumab or cetuximab, developed skin toxicities and were biopsied as standard of care for skin rash at the Department of Dermatology, Northwestern University.
Who may be able to join
- Patients treated with lapatinib who developed skin toxicities and were biopsied.
- Patients treated with erlotinib, cetuximab, or panitumumab who have been biopsied for skin rash.
Who cannot join
- Patients who do not fit above criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Histological Characterization and Differentiation of Rash From Other EGFR Inhibitors
The purpose of this study is to characterize the microscopic findings of skin rash associated with the use of chemotherapeutic anticancer agents known as epidermal growth factor inhibitors (EGFRIs).
Read the detailed description
Epidermal growth factor (EGF) and its receptor, the EGFR, are known to be key drivers in cellular proliferation and survival. Malignant tumors result from uncontrolled cell proliferation. The use of drugs which target the EGF receptor has offered patients with non-small cell lung cancer, pancreatic cancer, head and neck cancer, and colorectal cancer additional targeted anti-cancer therapy in addition to their chemotherapeutic regimens. As a result of increased use of these EGFR inhibitors, adverse events have emerged involving the skin, hair, nails and eyes. While the EGFR inhibitors block the signal transduction that interfere with cellular proliferation and survival of cancerous cells, they also affect the normal EGF function in the skin (papulopustular rash), hair, and nails. In this study, we seek to histologically characterize the papulopustular rash in patients who have been treated with lapatinib and compare our findings with those associated with three other EGFRIs, cetuximab, erlotinib and panitumumab.
- Conditions
- Skin Rash
- Being tested
- Skin Biopsy of Skin Rash Secondary to EGFRI Use
- Keywords
- skin rash, lapatinib, cetuximab, erlotinib, panitumumab
- Medical subject headings
- Exanthema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Biopsy of Skin Rash Secondary to EGFRI UseProcedure or surgery
Patients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study.
| Study group | Role | What they receive |
|---|---|---|
| L | Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash. Receives: Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use | |
| C | Patients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash. Receives: Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use | |
| P | Patients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash. Receives: Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use | |
| E | Patients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash. Receives: Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Skin RashStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Mario Lacouture, MD, Principal investigator, Northwestern University, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709878
- Sponsor's protocol ID
- GSK-Lapatinib
- Status last verified
- Feb 2015
- First submitted
- 1 Jul 2008
- Last updated
- 17 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gullick WJ. The Type 1 growth factor receptors and their ligands considered as a complex system. Endocr Relat Cancer. 2001 Jun;8(2):75-82. doi: 10.1677/erc.0.0080075.
PubMed 11397665Marmor MD, Skaria KB, Yarden Y. Signal transduction and oncogenesis by ErbB/HER receptors. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):903-13. doi: 10.1016/j.ijrobp.2003.06.002.
PubMed 14967450Schlessinger J. Cell signaling by receptor tyrosine kinases. Cell. 2000 Oct 13;103(2):211-25. doi: 10.1016/s0092-8674(00)00114-8. No abstract available.
PubMed 11057895Robert C, Soria JC, Spatz A, Le Cesne A, Malka D, Pautier P, Wechsler J, Lhomme C, Escudier B, Boige V, Armand JP, Le Chevalier T. Cutaneous side-effects of kinase inhibitors and blocking antibodies. Lancet Oncol. 2005 Jul;6(7):491-500. doi: 10.1016/S1470-2045(05)70243-6.
PubMed 15992698Fuchs E, Raghavan S. Getting under the skin of epidermal morphogenesis. Nat Rev Genet. 2002 Mar;3(3):199-209. doi: 10.1038/nrg758.
PubMed 11972157Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.
PubMed 16990857Jost M, Kari C, Rodeck U. The EGF receptor - an essential regulator of multiple epidermal functions. Eur J Dermatol. 2000 Oct-Nov;10(7):505-10.
PubMed 11056418Rodeck U, Jost M, Kari C, Shih DT, Lavker RM, Ewert DL, Jensen PJ. EGF-R dependent regulation of keratinocyte survival. J Cell Sci. 1997 Jan;110 ( Pt 2):113-21. doi: 10.1242/jcs.110.2.113.
PubMed 9044042Peus D, Hamacher L, Pittelkow MR. EGF-receptor tyrosine kinase inhibition induces keratinocyte growth arrest and terminal differentiation. J Invest Dermatol. 1997 Dec;109(6):751-6. doi: 10.1111/1523-1747.ep12340759.
PubMed 9406816Hauser PJ, Agrawal D, Hackney J, Pledger WJ. STAT3 activation accompanies keratinocyte differentiation. Cell Growth Differ. 1998 Oct;9(10):847-55.
PubMed 9790496Mimeault M, Bonenfant D, Batra SK. New advances on the functions of epidermal growth factor receptor and ceramides in skin cell differentiation, disorders and cancers. Skin Pharmacol Physiol. 2004 Jul-Aug;17(4):153-66. doi: 10.1159/000078818.
PubMed 15258446Woodworth CD, Michael E, Marker D, Allen S, Smith L, Nees M. Inhibition of the epidermal growth factor receptor increases expression of genes that stimulate inflammation, apoptosis, and cell attachment. Mol Cancer Ther. 2005 Apr;4(4):650-8. doi: 10.1158/1535-7163.MCT-04-0238.
PubMed 15827339Lorch JH, Klessner J, Park JK, Getsios S, Wu YL, Stack MS, Green KJ. Epidermal growth factor receptor inhibition promotes desmosome assembly and strengthens intercellular adhesion in squamous cell carcinoma cells. J Biol Chem. 2004 Aug 27;279(35):37191-200. doi: 10.1074/jbc.M405123200. Epub 2004 Jun 16.
PubMed 15205458Pastore S, Mascia F, Mariotti F, Dattilo C, Mariani V, Girolomoni G. ERK1/2 regulates epidermal chemokine expression and skin inflammation. J Immunol. 2005 Apr 15;174(8):5047-56. doi: 10.4049/jimmunol.174.8.5047.
PubMed 15814736Fisher GJ, Datta SC, Talwar HS, Wang ZQ, Varani J, Kang S, Voorhees JJ. Molecular basis of sun-induced premature skin ageing and retinoid antagonism. Nature. 1996 Jan 25;379(6563):335-9. doi: 10.1038/379335a0.
PubMed 8552187
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Characterization and Differentiation of Rash From Other EGFR Inhibitors
- ClinicalTrials.gov ID
- NCT00709878
- Acronym / sponsor ID
- GSK-Lapatinib
- Conditions
- Skin Rash
- Keywords
- skin rash, lapatinib, cetuximab, erlotinib, panitumumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Jul 2008 (estimated)
- Results
- Posted 23 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to characterize the microscopic findings of skin rash associated with the use of chemotherapeutic anticancer agents known as epidermal growth factor inhibitors (EGFRIs).
Detailed description
Epidermal growth factor (EGF) and its receptor, the EGFR, are known to be key drivers in cellular proliferation and survival. Malignant tumors result from uncontrolled cell proliferation. The use of drugs which target the EGF receptor has offered patients with non-small cell lung cancer, pancreatic cancer, head and neck cancer, and colorectal cancer additional targeted anti-cancer therapy in addition to their chemotherapeutic regimens. As a result of increased use of these EGFR inhibitors, adverse events have emerged involving the skin, hair, nails and eyes. While the EGFR inhibitors block the signal transduction that interfere with cellular proliferation and survival of cancerous cells, they also affect the normal EGF function in the skin (papulopustular rash), hair, and nails. In this study, we seek to histologically characterize the papulopustular rash in patients who have been treated with lapatinib and compare our findings with those associated with three other EGFRIs, cetuximab, erlotinib and panitumumab.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| L | – | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI UsePatients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash. |
| C | – | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI UsePatients treated with cetuximab who developed skin toxicities and have been biopsied for skin rash. |
| P | – | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI UsePatients treated with panitumumab who developed skin toxicities and have been biopsied for skin rash. |
| E | – | Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI UsePatients treated with erlotinib who developed skin toxicities and have been biopsied for a skin rash. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients selected for this study were treated with lapatinib, erlotinib, panitumumab or cetuximab, developed skin toxicities and were biopsied as standard of care for skin rash at the Department of Dermatology, Northwestern University.
Key inclusion criteria (2 listed)
- Patients treated with lapatinib who developed skin toxicities and were biopsied.
- Patients treated with erlotinib, cetuximab, or panitumumab who have been biopsied for skin rash.
Key exclusion criteria (1 listed)
- Patients who do not fit above criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Biopsy of Skin Rash Secondary to EGFRI UsePatients who were treated with lapatinib, cetuximab, panitumumab or erlotinib who subsequently developed a skin rash have been biopsied as standard of care. The biopsies will be used for this study. | Procedure or surgery | C, E, L, P |
Primary outcome
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11397665Gullick WJ. The Type 1 growth factor receptors and their ligands considered as a complex system. Endocr Relat Cancer. 2001 Jun;8(2):75-82. doi: 10.1677/erc.0.0080075.
- Background: PubMed 14967450Marmor MD, Skaria KB, Yarden Y. Signal transduction and oncogenesis by ErbB/HER receptors. Int J Radiat Oncol Biol Phys. 2004 Mar 1;58(3):903-13. doi: 10.1016/j.ijrobp.2003.06.002.
- Background: PubMed 11057895Schlessinger J. Cell signaling by receptor tyrosine kinases. Cell. 2000 Oct 13;103(2):211-25. doi: 10.1016/s0092-8674(00)00114-8. No abstract available.
- Background: PubMed 15992698Robert C, Soria JC, Spatz A, Le Cesne A, Malka D, Pautier P, Wechsler J, Lhomme C, Escudier B, Boige V, Armand JP, Le Chevalier T. Cutaneous side-effects of kinase inhibitors and blocking antibodies. Lancet Oncol. 2005 Jul;6(7):491-500. doi: 10.1016/S1470-2045(05)70243-6.
- Background: PubMed 11972157Fuchs E, Raghavan S. Getting under the skin of epidermal morphogenesis. Nat Rev Genet. 2002 Mar;3(3):199-209. doi: 10.1038/nrg758.
- Background: PubMed 16990857Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.
- Background: PubMed 11056418Jost M, Kari C, Rodeck U. The EGF receptor - an essential regulator of multiple epidermal functions. Eur J Dermatol. 2000 Oct-Nov;10(7):505-10.
- Background: PubMed 9044042Rodeck U, Jost M, Kari C, Shih DT, Lavker RM, Ewert DL, Jensen PJ. EGF-R dependent regulation of keratinocyte survival. J Cell Sci. 1997 Jan;110 ( Pt 2):113-21. doi: 10.1242/jcs.110.2.113.
- Background: PubMed 9406816Peus D, Hamacher L, Pittelkow MR. EGF-receptor tyrosine kinase inhibition induces keratinocyte growth arrest and terminal differentiation. J Invest Dermatol. 1997 Dec;109(6):751-6. doi: 10.1111/1523-1747.ep12340759.
- Background: PubMed 9790496Hauser PJ, Agrawal D, Hackney J, Pledger WJ. STAT3 activation accompanies keratinocyte differentiation. Cell Growth Differ. 1998 Oct;9(10):847-55.
- Background: PubMed 15258446Mimeault M, Bonenfant D, Batra SK. New advances on the functions of epidermal growth factor receptor and ceramides in skin cell differentiation, disorders and cancers. Skin Pharmacol Physiol. 2004 Jul-Aug;17(4):153-66. doi: 10.1159/000078818.
- Background: PubMed 15827339Woodworth CD, Michael E, Marker D, Allen S, Smith L, Nees M. Inhibition of the epidermal growth factor receptor increases expression of genes that stimulate inflammation, apoptosis, and cell attachment. Mol Cancer Ther. 2005 Apr;4(4):650-8. doi: 10.1158/1535-7163.MCT-04-0238.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Lacouture, MD principal investigator
Northwestern University, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Rash, run by Northwestern University at 1 site in United States.
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 2 inclusion and 1 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2010). 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?
Differences in Histologic Alterations in Rash Caused by Lapatinib, a Dual HER1/2 Inhibitor (HER1/2i), and the Single HER1 Inhibitors (HER1i) Cetuximab, Erlotinib,and Panitumumab. (time frame: 6 months). 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 NCT00709878, which also lists 24 linked publications.
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 17 Mar 2015.