drugset / Trial / NCT00601640
Eflornithine and/or Diclofenac in Treating Patients With Sun-Damaged Skin
RandomizedParallel-groupOpen-labelPrevention
Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of eflornithine and diclofenac may stop cancer from growing in patients with sun-damaged skin. PURPOSE: This randomized phase II trial is studying the side effects and how well eflornithine works compared with diclofenac, given alone or together, in treating patients with sun-damaged skin.
Timeline
- Start
- 2007-01
- Primary completion
- 2010-02
- Completion
- 2014-12
Publications
- Background Bozzo P, Saboda K, Einspahr JG, Ranger-Moore J, Farmer ER, Cockerell CJ, Elder DE, Bangert JL, Hart N, Kramer CB, Alberts DS. Reliability and validity of a histologic score as a marker for skin cancer chemoprevention studies. Anal Quant Cytol Histol. 2003 Oct;25(5):285-92.
- Jeter JM, Curiel-Lewandrowski C, Stratton SP, Myrdal PB, Warneke JA, Einspahr JG, Bartels HG, Yozwiak M, Bermudez Y, Hu C, Bartels P, Alberts DS. Phase IIB Randomized Study of Topical Difluoromethylornithine and Topical Diclofenac on Sun-Damaged Skin of the Forearm. Cancer Prev Res (Phila). 2016 Feb;9(2):128-34. doi: 10.1158/1940-6207.CAPR-15-0232. Epub 2015 Dec 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Diclofenac | Other / unclassified | — | Topical |
| Subject | Eflornithine | Small molecule | — | Topical |