NCT00709878

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
2 months until next milestone

Results Posted

Study results publicly available

September 23, 2010

Completed
Last Updated

March 17, 2015

Status Verified

February 1, 2015

Enrollment Period

2.3 years

First QC Date

July 1, 2008

Results QC Date

August 27, 2010

Last Update Submit

February 24, 2015

Conditions

Skin Rash

Keywords

skin rash, lapatinib, cetuximab, erlotinib, panitumumab

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (4)

L

Patients treated with lapatinib who developed skin toxicities and have been biopsied for skin rash.

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.

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.

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.

Procedure: Skin Biopsy of Skin Rash Secondary to EGFRI Use

Interventions

Skin Biopsy of Skin Rash Secondary to EGFRI UsePROCEDURE

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.

CELP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who do not fit above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (24)

  • 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.

    PMID: 11397665BACKGROUND

  • Marmor 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.

    PMID: 14967450BACKGROUND

  • Schlessinger 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.

    PMID: 11057895BACKGROUND

  • Robert 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.

    PMID: 15992698BACKGROUND

  • Fuchs E, Raghavan S. Getting under the skin of epidermal morphogenesis. Nat Rev Genet. 2002 Mar;3(3):199-209. doi: 10.1038/nrg758.

    PMID: 11972157BACKGROUND

  • Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.

    PMID: 16990857BACKGROUND

  • Jost 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.

    PMID: 11056418BACKGROUND

  • Rodeck 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.

    PMID: 9044042BACKGROUND

  • Peus 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.

    PMID: 9406816BACKGROUND

  • Hauser PJ, Agrawal D, Hackney J, Pledger WJ. STAT3 activation accompanies keratinocyte differentiation. Cell Growth Differ. 1998 Oct;9(10):847-55.

    PMID: 9790496BACKGROUND

  • Mimeault 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.

    PMID: 15258446BACKGROUND

  • Woodworth 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.

    PMID: 15827339BACKGROUND

  • Lorch 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.

    PMID: 15205458BACKGROUND

  • Pastore 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.

    PMID: 15814736BACKGROUND

  • Fisher 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.

    PMID: 8552187BACKGROUND

  • El-Abaseri TB, Putta S, Hansen LA. Ultraviolet irradiation induces keratinocyte proliferation and epidermal hyperplasia through the activation of the epidermal growth factor receptor. Carcinogenesis. 2006 Feb;27(2):225-31. doi: 10.1093/carcin/bgi220. Epub 2005 Aug 25.

    PMID: 16123117BACKGROUND

  • Moy B, Goss PE. Lapatinib: current status and future directions in breast cancer. Oncologist. 2006 Nov-Dec;11(10):1047-57. doi: 10.1634/theoncologist.11-10-1047.

    PMID: 17110623BACKGROUND

  • Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro JM, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson RI, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. J Clin Oncol. 2002 Jan 1;20(1):110-24. doi: 10.1200/JCO.2002.20.1.110.

    PMID: 11773160BACKGROUND

  • Busse D, Doughty RS, Ramsey TT, Russell WE, Price JO, Flanagan WM, Shawver LK, Arteaga CL. Reversible G(1) arrest induced by inhibition of the epidermal growth factor receptor tyrosine kinase requires up-regulation of p27(KIP1) independent of MAPK activity. J Biol Chem. 2000 Mar 10;275(10):6987-95. doi: 10.1074/jbc.275.10.6987.

    PMID: 10702262BACKGROUND

  • Perez-Soler R, Delord JP, Halpern A, Kelly K, Krueger J, Sureda BM, von Pawel J, Temel J, Siena S, Soulieres D, Saltz L, Leyden J. HER1/EGFR inhibitor-associated rash: future directions for management and investigation outcomes from the HER1/EGFR inhibitor rash management forum. Oncologist. 2005 May;10(5):345-56. doi: 10.1634/theoncologist.10-5-345.

    PMID: 15851793BACKGROUND

  • Molinari E, De Quatrebarbes J, Andre T, Aractingi S. Cetuximab-induced acne. Dermatology. 2005;211(4):330-3. doi: 10.1159/000088502.

    PMID: 16286741BACKGROUND

  • Nelson MH, Dolder CR. Lapatinib: a novel dual tyrosine kinase inhibitor with activity in solid tumors. Ann Pharmacother. 2006 Feb;40(2):261-9. doi: 10.1345/aph.1G387. Epub 2006 Jan 17.

    PMID: 16418322BACKGROUND

  • Cameron D. Lapatinib plus capecitabine in patients with HER2-positive advanced breast cancer. Clin Adv Hematol Oncol. 2007 Jun;5(6):456-8. No abstract available.

    PMID: 17679920BACKGROUND

  • Nardone B, Nicholson K, Newman M, Guitart J, Gerami P, Talarico N, Yang XJ, Rademaker A, West DP, Lacouture ME. Histopathologic and immunohistochemical characterization of rash to human epidermal growth factor receptor 1 (HER1) and HER1/2 inhibitors in cancer patients. Clin Cancer Res. 2010 Sep 1;16(17):4452-60. doi: 10.1158/1078-0432.CCR-10-0421. Epub 2010 Aug 23.

    PMID: 20732960RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Skin tissue biopsies.

MeSH Terms

Conditions

Exanthema

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

Small sample size

Results Point of Contact

Title
Mario Lacouture, MD
Organization
Northwestern University
LacoutuM@mskcc.org
212-610-0079

Study Officials

  • Mario Lacouture, MD

    Northwestern University, Department of Dermatology

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 17, 2015

Results First Posted

September 23, 2010

Record last verified: 2015-02

Locations

US(1)