Crisaborole Ointment for Skin Toxicity Induced by Cetuximab (COSTIC)

November 3, 2023 updated by: WeiWei Xiao, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • WeiWei Xiao
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
crisaborole ointment
Drug: Cetuximab
Cetuximab
Drug: Crisaborole Ointment
Crisaborole ointment to be applied twice daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission rate of EGFR inhibitor-related acneiform eruption
Time Frame: 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.
From date of randomization until the date of remission，assessed up to 8 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission time of EGFR inhibitor-related acneiform eruption
Time Frame: 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
From date of randomization until the date of remission，assessed up to 8 weeks.
Cetuximab treatment discontinuation rate
Time Frame: 8 weeks from randomization.
Rate of Cetuximab treatment discontinuation due to skin toxicity
8 weeks from randomization.
Cetuximab dose reduction rate
Time Frame: 8 weeks from randomization.
Rate of Cetuximab dose reduction due to skin toxicity
8 weeks from randomization.
Level of paronychia, xeroderma and pruritus
Time Frame: 8 weeks from randomization.
Grading of paronychia, xeroderma and pruritus would be assessed according to NCI-CTCAE 5.0.
8 weeks from randomization.
Quality of life (FACT-EGFRI-18)
Time Frame: 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）
The 0,2,4,6,8,10,12 weeks from randomization.
Quality of life（EORTC QLQ-C30)
Time Frame: 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)
The 0,2,4,6,8,10,12 weeks from randomization.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Weiwei Xiao, Sun Yat-sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 31, 2023

First Submitted That Met QC Criteria

November 3, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2022-648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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