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

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

NCT ID: NCT06358677

Condition: Metastatic Colon Cancer
Metastatic Rectum Cancer

Conditions: Official terms:
Rectal Neoplasms
Tretinoin

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: This is a randomized, double-blind, split-face, phase II study of topical tretinoin prophylaxis for anti-EGFR treatment-induced skin toxicity in metastatic colorectal cancer.

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Masking description: Patients will apply topical tretinoin to one half of the face and topical moisturizer (placebo) to the other half of the face daily starting the day that anti-EGFR treatment is initiated. The sides of the face tretinoin and moisturizer are applied to will be randomized. Standardized photographs of the face will be obtained at screening and every two weeks from Week 1 Day 1 until after six weeks of treatment. Photographs will be graded by a dermatologist who will be blinded to treatment sidedness. Facial rash severity will be graded using a modified Investigators Global Assessment (IGA) score.

Intervention:

Intervention type: Drug
Intervention name: Topical Tretinoin
Description: Topical tretinoin will be applied to one half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.
Arm group label: Tretinoin half of face (left) and Placebo/Moisturizer other half of the face (right)

Intervention type: Other
Intervention name: Placebo
Description: A placebo (topical moisturizer) will be applied to the other half of the face, either left or right side. The side the topical tretinoin will be applied to will be randomized.
Arm group label: Tretinoin half of face (right) and Placebo/Moisturizer other half of the face (left)

Other name: Topical Moisturizer

Summary: 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.

Criteria for eligibility:
Criteria:
Inclusion 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: --Hepatic: - 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: --< 50 years of age: - 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). --≥ 50 years of age: - 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. Exclusion Criteria: - 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. --Note: Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. - 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Huntsman Cancer Institute at University of Utah

Address:
City: Salt Lake City
Zip: 84112
Country: United States

Status: Recruiting

Contact:
Last name: Susan Sharry

Phone: 801-585-3453
Email: susan.sharry@hci.utah.edu

Start date: June 21, 2024

Completion date: July 2029

Lead sponsor:
Agency: University of Utah
Agency class: Other

Source: University of Utah

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06358677