Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Cahaba Pharmaceuticals.
Recruitment status was:  Recruiting
Information provided by:
Cahaba Pharmaceuticals Identifier:
First received: April 6, 2010
Last updated: April 8, 2010
Last verified: April 2010
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.

Condition Intervention Phase
Palmar-Plantar Erythrodysesthesia
Breast Cancer
Drug: Ointment
Drug: 0.1% Uracil Ointment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer Treated With Capecitabine

Resource links provided by NLM:

Further study details as provided by Cahaba Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of Grade 2 and 3 HFS as graded by Roche Criteria [ Time Frame: Maximum of 6 months of therapy ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: Yes ]
    Pharmacokinetic levels will be drawn at specific intervals

Secondary Outcome Measures:
  • Anti-Tumor efficacy of Capecitabine [ Time Frame: Maximum of 6 months of therapy ] [ Designated as safety issue: Yes ]
    RECIST - Radiologic Criteria for subjects with measurable disease

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Lotion Drug: Ointment
Twice daily lotion to prevent HFS
Experimental: 0.1% Uracil Drug: 0.1% Uracil Ointment
Twice daily lotion to prevent HFS

Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Females, at least 18 years old
  • Histologically or cytologically confirmed metastatic breast cancer
  • You also cannot have any ulcerations or open wounds on palms of hands or soles of feet

Exclusion Criteria:

  • Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C)prior to entering the study or if you have not recovered to Grade 1 or better (except for alopecia)from adverse events due to agents administered more than 2 weeks earlier.
  • Use vitamin 6, chronic use of Cox-2 inhibitors, use full-dose anti- coagulants or use nicotine patches.

The above is not a complete list of eligibility criteria. Please see your study doctor for more information.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01100463

United States, Alabama
Bruno Cancer Center
Birmingham, Alabama, United States, 35205
United States, California
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
United States, Indiana
Research Institute of Deaconess Clinic
Evansville, Indiana, United States, 47713
Cancer Care Center
New Albany, Indiana, United States, 47150
United States, Kansas
Kansas City Cancer Centers
Overland Park, Kansas, United States, 66210
United States, Ohio
Signal Point Clinical Research Center
Middleton, Ohio, United States, 45042
Sponsors and Collaborators
Cahaba Pharmaceuticals
Principal Investigator: James Cantrell, MD Birmingham Hematology/Oncology Associates
  More Information

Responsible Party: James Cantrell, MD, Birmingham Hematology/Oncology Associates LLC Identifier: NCT01100463     History of Changes
Other Study ID Numbers: OIC-1UO-C001 
Study First Received: April 6, 2010
Last Updated: April 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Cahaba Pharmaceuticals:
HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Hand-Foot Syndrome
Neoplasms by Site
Breast Diseases
Skin Diseases
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on January 14, 2017