Crisaborole Ointment for Skin Toxicity Induced by Cetuximab

Metastatic Colorectal Cancer Clinical Trial

— COSTIC  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118047
• Other study ID #: B2022-648
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2023
• Source: Sun Yat-sen University
• Contact: Weiwei Xiao
• Phone: +8613710390520
• Email: xiaoww[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cetuximab
• Colorectal Neoplasms
• Metastatic Colorectal Cancer
• Skin Toxicity

Intervention

Drug:
• Crisaborole Ointment
Crisaborole ointment to be applied twice daily.
• Cetuximab
Cetuximab

Locations

Country	Name	City	State
China	WeiWei Xiao	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Remission time of EGFR inhibitor-related acneiform eruption	Grading of acneiform eruption would be assessed according to NCI-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	Cetuximab treatment discontinuation rate	Rate of Cetuximab treatment discontinuation due to skin toxicity	8 weeks from randomization.
Secondary	Cetuximab dose reduction rate	Rate of Cetuximab dose reduction due to skin toxicity	8 weeks from randomization.
Secondary	Level of paronychia, xeroderma and pruritus	Grading of paronychia, xeroderma and pruritus would be assessed according to NCI-CTCAE 5.0.	8 weeks from randomization.
Secondary	Quality of life (FACT-EGFRI-18)	Functional Assessment of Cancer Therapy (FACT)questionnaire to assess dermatologic symptoms associated with epidermal growth factor receptor inhibitors (FACT-EGFRI-18)	The 0,2,4,6,8,10,12 weeks from randomization.
Secondary	Quality of life(EORTC QLQ-C30)	Questionnaire of the European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)	The 0,2,4,6,8,10,12 weeks from randomization.