RECRUITING

Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer

Conditions

Metastatic Colon Cancer Metastatic Rectum Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this clinical trial is to learn if using topical tretinoin will help patients with colorectal cancer who are experiencing an acneiform rash as a side effect of their treatment. Researchers will compare the use of tretinoin on one side of the face to the use of a placebo on the other side of the face to see if there is an impact.

Official Title

Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Metastatic Colorectal Cancer

Quick Facts

Study Start:2024-06-21

Study Completion:2029-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06358677

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Participant aged ≥ 18 years * Histologically confirmed colorectal cancer. * Radiologically confirmed metastatic disease. * Eligible for and willing to receive treatment with panitumumab or cetuximab as standard-of-care. * ECOG Performance Status ≤ 2. * Adequate organ function as defined as: * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN. * Negative pregnancy test for participants who have not undergone surgical sterilization or shown evidence of post-menopausal status. The following age-specific requirements apply: * Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and * Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or * Underwent surgical sterilization (bilateral oophorectomy or hysterectomy). * Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or * Had radiation-induced menopause with last menses \>1 year ago; or * Had chemotherapy-induced menopause with last menses \>1 year ago; or * Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy). * Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.2. * Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events less than or equal to grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by an investigator with appropriate documentation. * Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.	* Prior treatment with an anti-EGFR agent. * Pre-existing facial rash with an IGA score of \>2 or that per the treating investigator would preclude the ability to assess response to topical tretinoin. * The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6). * Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures. * Systemic active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C. * Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study. * Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3). * Participants taking prohibited medications as described in Section 6.8.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

Inclusion Criteria

Exclusion Criteria

* Participant aged ≥ 18 years
* Histologically confirmed colorectal cancer.
* Radiologically confirmed metastatic disease.
* Eligible for and willing to receive treatment with panitumumab or cetuximab as standard-of-care.
* ECOG Performance Status ≤ 2.
* Adequate organ function as defined as:
* Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)
* AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN ----Participants with liver metastases will be allowed to enroll with AST and ALT levels ≤ 5 x ULN.
* Negative pregnancy test for participants who have not undergone surgical sterilization or shown evidence of post-menopausal status. The following age-specific requirements apply:
* Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
* Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
* Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
* Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
* Had radiation-induced menopause with last menses \>1 year ago; or
* Had chemotherapy-induced menopause with last menses \>1 year ago; or
* Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
* Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception as described in Section 5.4.2.
* Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events less than or equal to grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by an investigator with appropriate documentation.
* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.

* Prior treatment with an anti-EGFR agent.
* Pre-existing facial rash with an IGA score of \>2 or that per the treating investigator would preclude the ability to assess response to topical tretinoin.
* The diagnosis of another malignancy within ≤ 2 years before study enrollment, except for those considered to be adequately treated with no evidence of disease or symptoms and/or will not require therapy during the study duration (i.e., basal cell or squamous cell skin cancer, carcinoma in situ of the breast, bladder or of the cervix, or low-grade prostate cancer with Gleason Score ≤ 6).
* Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
* Systemic active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination, radiographic findings, and TB testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), or hepatitis C.
* Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
* Known prior severe hypersensitivity to investigational product or any component in its formulations (CTCAE v5.0 Grade ≥ 3).
* Participants taking prohibited medications as described in Section 6.8.2. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

Contacts and Locations

Study Contact

Susan Sharry

CONTACT

801-585-3453

susan.sharry@hci.utah.edu

Principal Investigator

Christopher Nevala-Plagemann, MD

PRINCIPAL_INVESTIGATOR

Huntsman Cancer Institute

Study Locations (Sites)

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: University of Utah

Christopher Nevala-Plagemann, MD, PRINCIPAL_INVESTIGATOR, Huntsman Cancer Institute

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 Registration Dates

Study Start Date2024-06-21

Study Completion Date2029-07

Study Record Updates

Study Start Date2024-06-21

Study Completion Date2029-07

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Colon Cancer
Metastatic Rectum Cancer