Clinical trial NCT06118047: Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
Official title: Efficacy and Safety of Crisaborole Ointment, a Phosphodiesterase 4 (PDE4) Inhibitor, for the Topical Treatment of Cetuximab-Related Skin Toxicity Among Metastatic Colorectal Cancer Patients：A Prospective, Single-arm, Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Metastatic Colorectal Cancer
Cetuximab
Skin Toxicity
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The efficacy of cetuximab has been demonstrated in treating metastatic colorectal cancer (mCRC). Skin toxicities, especially acneiform eruption, are the major side effects associated with cetuximab, which affect patients' quality of life and can lead to treatment discontinuation and cetuximab dose reduction.

This prospective, single-arm, phase II clinical trial aims to explore the efficacy and safety of crisaborole ointment in Cetuximab-Related Skin Toxicity. A total of 33 mCRC patients with acneiform eruption will be enrolled. All of the participants will receive crisaborole ointment twice daily. The total follow-up time is 12 weeks.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Remission rate of EGFR inhibitor-related acneiform eruption
timeFrame: From date of randomization until the date of remission，assessed up to 8 weeks.
Secondary outcomes:
measure: Remission time of EGFR inhibitor-related acneiform eruption
timeFrame: From date of randomization until the date of remission，assessed up to 8 weeks.
measure: Cetuximab treatment discontinuation rate
timeFrame: 8 weeks from randomization.
measure: Cetuximab dose reduction rate
timeFrame: 8 weeks from randomization.
measure: Level of paronychia, xeroderma and pruritus
timeFrame: 8 weeks from randomization.
measure: Quality of life (FACT-EGFRI-18)
timeFrame: The 0,2,4,6,8,10,12 weeks from randomization.
measure: Quality of life（EORTC QLQ-C30)
timeFrame: The 0,2,4,6,8,10,12 weeks from randomization.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: WeiWei Xiao
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Weiwei Xiao
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.