topical tretinoin prophylaxis for anti-egfr induced skin toxicity in metastatic colorectal cancer

Conditions: Metastatic Colon Cancer; Metastatic Rectum Cancer

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.


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.