A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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 literature.
Secondary Objectives:
A. The proportion of participants who complete the treatment course, B. The change in AK count from baseline C. The proportion of participants who have clearance of >75% of AKs D. Differences in adverse event reporting, in particular redness, scaling, burning, pain, and itch, E. Comparison of counts of AK lesions by dermatologists in person to counts of AK lesions by dermatologists using standardized digital photography.
F. Change in MASCK metric G. Patient satisfaction (AK-EPQ) H. Change in health related QoL (AK-QoL) I. Patient adherence (ability to complete entire recommended course)
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Mackenzie Wehner, MD
- Phone Number: 713-792-6979
- Email: mwehner@mdanderson.org
Study Locations
-
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Texas
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Houston, Texas, United States, 77030
- Recruiting
- The University of Texas M. D. Anderson Cancer Center
-
Contact:
- Mackenzie Wehner, MD
- Phone Number: 713-792-6979
- Email: mwehner@mdanderson.org
-
Principal Investigator:
- Mackenzie Wehner, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 or efficacy assessment of the investigational regimen are eligible for this trial.
- The effects of topical fluorouracil and/or fluorouracil plus calcipotriene on the developing human fetus are unknown. From the topical fluorouracil package insert: "One birth defect (cleft lip and palate) has been reported in the newborn of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil."11 For this reason, we are excluding women of child-bearing potential. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
• Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
- Known allergy to any component of the medications or vehicle.
- A wound or suspected skin cancer within 5cm of the area to be treated
- Immunosuppression, or use in the past month of medications that could impede skin assessment including but not limited to:
Other topical medications with active ingredients including: topical steroids, topical calcineurin inhibitors, topical retinoids, imiquimod, diclofenac, etc.
Artificial tanners Cytotoxic medications including: systemic fluorouracil, bleomycin, doxorubicin, cisplatin, etc.
Ultraviolet therapy Oral nicotinamide Oral retinoids including: isotretinoin, acitretin
- History of hypercalcemia
- Clinical evidence of vitamin D toxicity
- The effects of topical fluorouracil and/or fluorouracil plus calcipotriene on the developing human fetus are unknown. From the topical fluorouracil package insert: "One birth defect (cleft lip and palate) has been reported in the newborn of a patient using EFUDEX as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when EFUDEX was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil."11 For this reason, we are excluding women of child-bearing potential. This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
Postmenopausal (no menses in greater than or equal to 12 consecutive months). History of hysterectomy or bilateral salpingo-oophorectomy. Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
History of bilateral tubal ligation or another surgical sterilization procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment with Fluorouracil and Calcipotriene
Participants will screened and enrolled during a standard-of-care clinical dermatology visit.
Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks
|
Participants in the fluorouracil/calcipotriene will apply fluorouracil/calcipotriene twice daily for 4 days to the affected area.
|
|
Experimental: Treatment with Fluorouracil
Participants will screened and enrolled during a standard-of-care clinical dermatology visit.
Participants will be randomized in between treatment with topical 5-FU twice daily for 2-3 weeks
|
Participants in the fluorouracil arm will apply fluorouracil twice daily for 2-3 weeks (depending on body area).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety and Adverse Events (AEs)
Time Frame: Through study completion; an average of 1 year.
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
|
Through study completion; an average of 1 year.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mackenzie Wehner, MD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-2003
- NCI-2025-01497 (Other Identifier: NCI-CTRP Clinical Trials Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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