Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors

Summary

The goal of this clinical trial is to learn if using topical tretinoin will help patients with solid tumors 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.

Timeline

Start

2025-02-19

Primary completion

2027-07

Completion

2029-07

Publications

• Background Van Cutsem E, Kohne CH, Lang I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S, Schlichting M, Zubel A, Celik I, Rougier P, Ciardiello F. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol. 2011 May 20;29(15):2011-9. doi: 10.1200/JCO.2010.33.5091. Epub 2011 Apr 18.
• Background Berlin J, Posey J, Tchekmedyian S, Hu E, Chan D, Malik I, Yang L, Amado RG, Hecht JR. Panitumumab with irinotecan/leucovorin/5-fluorouracil for first-line treatment of metastatic colorectal cancer. Clin Colorectal Cancer. 2007 Mar;6(6):427-32. doi: 10.3816/CCC.2007.n.011.
• Background Kohne CH, Hofheinz R, Mineur L, Letocha H, Greil R, Thaler J, Fernebro E, Gamelin E, Decosta L, Karthaus M. First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer. J Cancer Res Clin Oncol. 2012 Jan;138(1):65-72. doi: 10.1007/s00432-011-1061-6. Epub 2011 Sep 30.
• Background Watanabe J, Muro K, Shitara K, Yamazaki K, Shiozawa M, Ohori H, Takashima A, Yokota M, Makiyama A, Akazawa N, Ojima H, Yuasa Y, Miwa K, Yasui H, Oki E, Sato T, Naitoh T, Komatsu Y, Kato T, Hihara M, Soeda J, Misumi T, Yamamoto K, Akagi K, Ochiai A, Uetake H, Tsuchihara K, Yoshino T. Panitumumab vs Bevacizumab Added to Standard First-line Chemotherapy and Overall Survival Among Patients With RAS Wild-type, Left-Sided Metastatic Colorectal Cancer: A Randomized Clinical Trial. JAMA. 2023 Apr 18;329(15):1271-1282. doi: 10.1001/jama.2023.4428.
• Background Nevala-Plagemann C, Iyengar S, Trunk AD, Pappas L, Haaland B, Garrido-Laguna I. Treatment Trends and Clinical Outcomes of Left-Sided RAS/RAF Wild-Type Metastatic Colorectal Cancer in the United States. J Natl Compr Canc Netw. 2022 Feb 4;20(3):268-275. doi: 10.6004/jnccn.2021.7079.
• Background Ciliberto D, Staropoli N, Caglioti F, Chiellino S, Ierardi A, Ingargiola R, Botta C, Arbitrio M, Correale P, Tassone P, Tagliaferri P. The best strategy for RAS wild-type metastatic colorectal cancer patients in first-line treatment: A classic and Bayesian meta-analysis. Crit Rev Oncol Hematol. 2018 May;125:69-77. doi: 10.1016/j.critrevonc.2018.03.003. Epub 2018 Mar 9.
• Background Morris VK, Kennedy EB, Baxter NN, Benson AB 3rd, Cercek A, Cho M, Ciombor KK, Cremolini C, Davis A, Deming DA, Fakih MG, Gholami S, Hong TS, Jaiyesimi I, Klute K, Lieu C, Sanoff H, Strickler JH, White S, Willis JA, Eng C. Treatment of Metastatic Colorectal Cancer: ASCO Guideline. J Clin Oncol. 2023 Jan 20;41(3):678-700. doi: 10.1200/JCO.22.01690. Epub 2022 Oct 17.
• Background Lacouture ME, Anadkat M, Jatoi A, Garawin T, Bohac C, Mitchell E. Dermatologic Toxicity Occurring During Anti-EGFR Monoclonal Inhibitor Therapy in Patients With Metastatic Colorectal Cancer: A Systematic Review. Clin Colorectal Cancer. 2018 Jun;17(2):85-96. doi: 10.1016/j.clcc.2017.12.004. Epub 2017 Dec 13.
• Background Lacouture ME, Mitchell EP, Piperdi B, Pillai MV, Shearer H, Iannotti N, Xu F, Yassine M. Skin toxicity evaluation protocol with panitumumab (STEPP), a phase II, open-label, randomized trial evaluating the impact of a pre-Emptive Skin treatment regimen on skin toxicities and quality of life in patients with metastatic colorectal cancer. J Clin Oncol. 2010 Mar 10;28(8):1351-7. doi: 10.1200/JCO.2008.21.7828. Epub 2010 Feb 8.
• Background Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, Baldwin HE, Berson DS, Bowe WP, Graber EM, Harper JC, Kang S, Keri JE, Leyden JJ, Reynolds RV, Silverberg NB, Stein Gold LF, Tollefson MM, Weiss JS, Dolan NC, Sagan AA, Stern M, Boyer KM, Bhushan R. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016 May;74(5):945-73.e33. doi: 10.1016/j.jaad.2015.12.037. Epub 2016 Feb 17.
• Background Baldwin HE, Nighland M, Kendall C, Mays DA, Grossman R, Newburger J. 40 years of topical tretinoin use in review. J Drugs Dermatol. 2013 Jun 1;12(6):638-42.
• Background Schmidt N, Gans EH. Tretinoin: A Review of Its Anti-inflammatory Properties in the Treatment of Acne. J Clin Aesthet Dermatol. 2011 Nov;4(11):22-9.
• Background Holcmann M, Sibilia M. Mechanisms underlying skin disorders induced by EGFR inhibitors. Mol Cell Oncol. 2015 Jun 1;2(4):e1004969. doi: 10.1080/23723556.2015.1004969. eCollection 2015 Oct-Dec.
• Background Vezzoli P, Marzano AV, Onida F, Alessi E, Galassi B, Tomirotti M, Berti E. Cetuximab-induced acneiform eruption and the response to isotretinoin. Acta Derm Venereol. 2008;88(1):84-6. doi: 10.2340/00015555-0330. No abstract available.
• Background Gutzmer R, Werfel T, Mao R, Kapp A, Elsner J. Successful treatment with oral isotretinoin of acneiform skin lesions associated with cetuximab therapy. Br J Dermatol. 2005 Oct;153(4):849-51. doi: 10.1111/j.1365-2133.2005.06835.x. No abstract available.
• Background Kizilyel O, Metin MS, Elmas OF, Cayir Y, Aktas A. Effects of oral isotretinoin on lipids and liver enzymes in acne patients. Cutis. 2014 Nov;94(5):234-8.
• Background van Hoogdalem EJ. Transdermal absorption of topical anti-acne agents in man; review of clinical pharmacokinetic data. J Eur Acad Dermatol Venereol. 1998 Sep;11 Suppl 1:S13-9; discussion S28-9. doi: 10.1111/j.1468-3083.1998.tb00902.x.
• Background Kligman AM, Grove GL, Hirose R, Leyden JJ. Topical tretinoin for photoaged skin. J Am Acad Dermatol. 1986 Oct;15(4 Pt 2):836-59. doi: 10.1016/s0190-9622(86)70242-9.
• Background Griffiths CE, Kang S, Ellis CN, Kim KJ, Finkel LJ, Ortiz-Ferrer LC, White GM, Hamilton TA, Voorhees JJ. Two concentrations of topical tretinoin (retinoic acid) cause similar improvement of photoaging but different degrees of irritation. A double-blind, vehicle-controlled comparison of 0.1% and 0.025% tretinoin creams. Arch Dermatol. 1995 Sep;131(9):1037-44.
• Background Oken MM, Creech RH, Tormey DC, Horton J, Davis TE, McFadden ET, Carbone PP. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982 Dec;5(6):649-55. No abstract available.

Drugs

Indications