COSTIC: Crisaborole Ointment for Skin Toxicity Induced by Cetuximab
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group crisaborole ointment |
Drug: Crisaborole Ointment
Crisaborole ointment to be applied twice daily.
Drug: Cetuximab
Cetuximab
|
Outcome Measures
Primary Outcome Measures
- Remission rate of EGFR inhibitor-related acneiform eruption [From date of randomization until the date of remission，assessed up to 8 weeks.]
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.
Secondary Outcome Measures
- Remission time of EGFR inhibitor-related acneiform eruption [From date of randomization until the date of remission，assessed up to 8 weeks.]
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
- Cetuximab treatment discontinuation rate [8 weeks from randomization.]
Rate of Cetuximab treatment discontinuation due to skin toxicity
- Cetuximab dose reduction rate [8 weeks from randomization.]
Rate of Cetuximab dose reduction due to skin toxicity
- Level of paronychia, xeroderma and pruritus [8 weeks from randomization.]
Grading of paronychia, xeroderma and pruritus would be assessed according to NCI-CTCAE 5.0.
- Quality of life (FACT-EGFRI-18) [The 0,2,4,6,8,10,12 weeks from randomization.]
Functional Assessment of Cancer Therapy （FACT）questionnaire to assess dermatologic symptoms associated with epidermal growth factor receptor inhibitors （FACT-EGFRI-18）
- Quality of life（EORTC QLQ-C30) [The 0,2,4,6,8,10,12 weeks from randomization.]
Questionnaire of the European Organisation for Research and Treatment of Cancer quality of life (EORTC QLQ-C30)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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;
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | WeiWei Xiao | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
- Principal Investigator: Weiwei Xiao, Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- B2022-648