Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

NCT06118047 | Unknown Phase 2

• 1 other identifier: B2022-648
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-arm, phase II clinical trial that will enroll metastatic colorectal cancer patients with Cetuximab-Related Skin Toxicity, who will receive crisaborole ointment twice daily.

Conditions

Metastatic Colorectal Cancer; Cetuximab; Skin Toxicity

Outcome Measures

Primary Outcomes (1)

• Remission rate of EGFR inhibitor-related acneiform eruption

  Grading of acneiform eruption would be assessed according to National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE) 5.0. Remission was defined as a reduction in acneiform eruption from grade 2 to grade 1 or grade 3 to grade 2 sustained for at least 2 weeks.

  From date of randomization until the date of remission，assessed up to 8 weeks.

Secondary Outcomes (6)

• Remission time of EGFR inhibitor-related acneiform eruption

  From date of randomization until the date of remission，assessed up to 8 weeks.

• Cetuximab treatment discontinuation rate

  8 weeks from randomization.

• Cetuximab dose reduction rate

  8 weeks from randomization.

• Level of paronychia, xeroderma and pruritus

  8 weeks from randomization.

• Quality of life (FACT-EGFRI-18)

  The 0,2,4,6,8,10,12 weeks from randomization.

Study Arms (1)

Intervention group

EXPERIMENTAL

crisaborole ointment

Drug: Crisaborole Ointment; Drug: Cetuximab

Interventions

Crisaborole Ointment DRUG

Crisaborole ointment to be applied twice daily.

Intervention group

Cetuximab DRUG

Cetuximab

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed mCRC and undergoing Cetuximab treatment;
• ≥2 grade EGFR inhibitor-related acneiform eruption, evaluated by National Cancer Institute (NCI) Common Terminology Criteria Adverse Events (CTCAE）5.0;
• Age 18 years and older；
• ECOG performance status 0-2.；
• Bone marrow ,brain, heart, kidney and other organ function well;；
• Expected survival time more than 3 months;

You may not qualify if:

• The presence of any active skin disease；
• Undergoing any current hormone therapy for any other disease;
• Prior allergic reaction or severe intolerance to crisaborole ointment

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

WeiWei Xiao

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

• Kim YS, Ji JH, Oh SY, Lee S, Huh SJ, Lee JH, Song KH, Son CH, Roh MS, Lee GW, Lee J, Kim ST, Kim CK, Jang JS, Hwang IG, Ahn HK, Park LC, Oh SY, Kim SG, Lee SC, Lim DH, Lee SI, Kang JH. A Randomized Controlled Trial of Epidermal Growth Factor Ointment for Treating Epidermal Growth Factor Receptor Inhibitor-Induced Skin Toxicities. Oncologist. 2020 Jan;25(1):e186-e193. doi: 10.1634/theoncologist.2019-0221. Epub 2019 Sep 6.

  PMID: 31492766 BACKGROUND

• Klufa J, Bauer T, Hanson B, Herbold C, Starkl P, Lichtenberger B, Srutkova D, Schulz D, Vujic I, Mohr T, Rappersberger K, Bodenmiller B, Kozakova H, Knapp S, Loy A, Sibilia M. Hair eruption initiates and commensal skin microbiota aggravate adverse events of anti-EGFR therapy. Sci Transl Med. 2019 Dec 11;11(522):eaax2693. doi: 10.1126/scitranslmed.aax2693.

  PMID: 31826981 BACKGROUND

• Hofheinz RD, Lorenzen S, Trojan J, Ocvirk J, Ettrich TJ, Al-Batran SE, Schulz H, Homann N, Feustel HP, Schatz M, Kripp M, Schulte N, Tetyusheva M, Heeger S, Vlassak S, Merx K. EVITA-a double-blind, vehicle-controlled, randomized phase II trial of vitamin K1 cream as prophylaxis for cetuximab-induced skin toxicity. Ann Oncol. 2018 Apr 1;29(4):1010-1015. doi: 10.1093/annonc/mdy015.

  PMID: 29360920 BACKGROUND

• Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E; American Society of Clinical Oncology; European Society of Medical Oncology. Management of skin toxicity associated with cetuximab treatment in combination with chemotherapy or radiotherapy. Oncologist. 2011;16(2):228-38. doi: 10.1634/theoncologist.2010-0298. Epub 2011 Jan 27.

  PMID: 21273511 BACKGROUND

• Pinto C, Barone CA, Girolomoni G, Russi EG, Merlano MC, Ferrari D, Maiello E. Management of Skin Reactions During Cetuximab Treatment in Association With Chemotherapy or Radiotherapy: Update of the Italian Expert Recommendations. Am J Clin Oncol. 2016 Aug;39(4):407-15. doi: 10.1097/COC.0000000000000291.

  PMID: 27077276 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Weiwei Xiao

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiwei Xiao

CONTACT

+8613710390520; xiaoww@sysucc.org.cn

Liping Chen

CONTACT

+86 020 87340767; chenlp@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: August 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: November 7, 2023

Record last verified: 2023-07

Locations

CN (1)