A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to compare the effects of topical fluorouracil alone to topical fluorouracil plus topical calcipotriene in patients with multiple actinic keratoses. "Topical" means the medication is applied directly to the skin.
Description
Primary Objectives: The primary objective of this pilot trial is feasibility, specifically measured by percent of patients approached and screened who enroll in the study. The prior trial on these medications reported a 75% enrollment rate (132 enrolled of 175 patients screened), though other trials of AK treatments have had lower enrollment rates (e.g., 53%9). To accurately plan a multi-site trial and apply for funding, an enrollment rate from the pilot trial will be critical. We will consider 50% enrollment rate a success, based on the lowest enrollment rates we found in the AK trial litera…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to start treatment within 1 week of enrollment * Patients must be age ≥18, not of childbearing potential, and have the presence of 4-15 clinically, visibly confirmed and discrete AKs in an at least 25 cm2 contiguous area on the head, neck, arm, or hand. Because no dosing or adverse event data are currently available on the use of fluorouracil in combination with calcipotriene in patients \<18 years of age, children are excluded from this study. * Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety…
Interventions
- DrugFluorouracil 5-FU
Participants in the fluorouracil arm will apply fluorouracil twice daily for 2-3 weeks (depending on body area).
- DrugFluorouracil/Calcipotriene
Participants in the fluorouracil/calcipotriene will apply fluorouracil/calcipotriene twice daily for 4 days to the affected area.
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas