Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
RATIONALE: Drugs used in chemotherapy, such as tazarotene, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying topical tazarotene to see how well it works in treating patients with basal cell skin cancer and basal cell nevus syndrome on the face.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Single Arm Open-Label Clinical Trial of Chemotherapy of BCC's With Tazarotene 0.1% in Subjects With Basal Cell Nevus Syndrome|
- Complete Response Rate [ Time Frame: 36 months ]The primary endpoint used to evaluate tazarotene efficacy for BCC chemotherapy was the complete response (CR) rate, defined as the complete visible disappearance of a patient's "target" lesion during the the 18 months of tazarotene application and its failure to recur during the ensuing 18-months. We defined surgical removal of a target lesion as a treatment failure. The primary endpoint was assessed based on intention to treat analysis such that any subject who underwent the baseline evaluation and applied at least 1 dose of tazarotene was included in the analysis. Drop-outs were considered non-responders. A priori treatment success for tazarotene was defined as a CR rate of at least 50%, and treatment failure was defined as a CR rate of 25% or less.
- Time to Lesion Clearance [ Time Frame: 36 months ]
- Time to Progression [ Time Frame: 36 months ]
- Estimated Duration of Complete Response [ Time Frame: 36 months ]
- Overall Response at Treated Lesions [ Time Frame: 36 months ]
|Study Start Date:||July 2004|
|Study Completion Date:||June 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Tazarotene is a member of the acetylenic class of retinoids.
Other Name: tazorac
- Determine whether topical tazarotene, administered over a period of 18 months as a chemopreventive agent, reduces the incidence of basal cell carcinomas (BCCs) on treated skin in patients with basal cell nevus syndrome (BCNS).
- Expand and refine chemopreventive strategies in patients with BCNS who are at high risk for the development of BCCs.
OUTLINE: This is an open-label, multicenter study.
Patients apply topical tazarotene cream to the face once daily for 18 months in the absence of unacceptable toxicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489086
|United States, California|
|Children's Hospital and Research Center Oakland|
|Oakland, California, United States, 94609|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Ervin Epstein, MD||Children's Hospital & Research Center Oakland|
|Principal Investigator:||David R. Bickers, MD||Herbert Irving Comprehensive Cancer Center|