Clinical Trial: Topical Tazarotene in Treating Patients With Basal Cell Skin Cancer and Basal Cell Nevus Syndrome on the Face

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.


Detailed Summary:

OBJECTIVES:

  • 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.


Sponsor: Children's Hospital & Research Center Oakland

Current Primary Outcome: 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.


Original Primary Outcome: Complete Response Rate

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Time to Lesion Clearance
  • Time to Progression
  • Estimated Duration of Complete Response
  • Overall Response at Treated Lesions


Information By: Children's Hospital & Research Center Oakland

Dates:
Date Received: June 20, 2007
Date Started: July 2004
Date Completion:
Last Updated: January 13, 2016
Last Verified: January 2016