Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face
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|ClinicalTrials.gov Identifier: NCT00489086|
Recruitment Status : Completed
First Posted : June 21, 2007
Results First Posted : February 11, 2016
Last Update Posted : February 11, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplastic Syndrome||Drug: tazarotene||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||June 2012|
U.S. FDA Resources
Tazarotene is a member of the acetylenic class of retinoids.
Other Name: tazorac
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|