Clinical Trial: Study of 0.1% Uracil Ointment (1UO) Ointment for the Prevention of Hand-Foot Syndrome

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Phase 1-2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Profile of 0.1% Uracil Ointment (1UO)in the Prevention of

Brief Summary: The purpose of this research study is to see if combining uracil ointment (1UO) with capecitabine (Xeloda) can prevent Hand-Foot Syndrome. The study will also see what effects 1UO and capecitabine may have in patients with metastatic breast cancer.

Detailed Summary: Capecitabine is used in the treatment of human breast cancer among other human cancers. Following absorption, capecitabine is converted enzymatically to 5-fluorouracil (5-FU). The administration of capecitabine or 5-FU can cause a cutaneous toxicity known as hand-foot syndrome (HFS) or palmar-plantar erythrodysesthesia (PPE). HFS is progressive with dose and duration of exposure to 5-FU or capecitabine. HFS is characterized by progressive redness and cracking of hands and feet. Currently, there are no approved therapies for HFS.
Sponsor: Cahaba Pharmaceuticals

Current Primary Outcome:

  • Incidence of Grade 2 and 3 HFS as graded by Roche Criteria [ Time Frame: Maximum of 6 months of therapy ]
    • Time to first HFS event
    • Requirements for capecitabine dose reduction/interruption due to HFS
    • Digital Photos will be taken of the hands and feet at specific intervals
  • Serum Pharmacokinetic Levels of Uracil will be drawn [ Time Frame: Maximum of 6 months of therapy ]
    Pharmacokinetic levels will be drawn at specific intervals


Original Primary Outcome: Same as current

Current Secondary Outcome: Anti-Tumor efficacy of Capecitabine [ Time Frame: Maximum of 6 months of therapy ]

RECIST - Radiologic Criteria for subjects with measurable disease


Original Secondary Outcome: Same as current

Information By: Cahaba Pharmaceuticals

Dates:
Date Received: April 6, 2010
Date Started: December 2009
Date Completion: December 2011
Last Updated: April 8, 2010
Last Verified: April 2010