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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01100463
Recruitment Status : Unknown
Verified April 2010 by Cahaba Pharmaceuticals.
Recruitment status was:  Recruiting
First Posted : April 9, 2010
Last Update Posted : April 9, 2010
Information provided by:
Cahaba Pharmaceuticals

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.

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

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Estimated Primary Completion Date : September 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

  2. Serum Pharmacokinetic Levels of Uracil will be drawn [ Time Frame: Maximum of 6 months of therapy ]
    Pharmacokinetic levels will be drawn at specific intervals

Secondary Outcome Measures :
  1. Anti-Tumor efficacy of Capecitabine [ Time Frame: Maximum of 6 months of therapy ]
    RECIST - Radiologic Criteria for subjects with measurable disease

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01100463

Contact: Michael R Myers, BA, MA 410-889-2221
Contact: Joi Stone 866-877-7376 ext 3710

United States, Alabama
Bruno Cancer Center Recruiting
Birmingham, Alabama, United States, 35205
Contact: Brittany White    205-939-7880   
Principal Investigator: James Cantrell, MD         
United States, California
Comprehensive Cancer Center Not yet recruiting
Palm Springs, California, United States, 92262
Contact: Susan Sagle, RN    760-416-4734   
Principal Investigator: Cynthia Leichman, MD         
United States, Indiana
Research Institute of Deaconess Clinic Recruiting
Evansville, Indiana, United States, 47713
Contact: Lou Ann Shoaff    812-426-9390   
Principal Investigator: Maqbool Ahmed, MD         
Cancer Care Center Recruiting
New Albany, Indiana, United States, 47150
Contact: Denette Grider, RN    812-945-4000 ext 113      
Principal Investigator: Naveed Chowhan, MD         
United States, Kansas
Kansas City Cancer Centers Recruiting
Overland Park, Kansas, United States, 66210
Contact: Cathy Wight    913-541-4672   
Principal Investigator: Kelly Pendergrass, MD         
United States, Ohio
Signal Point Clinical Research Center Recruiting
Middleton, Ohio, United States, 45042
Contact: Heather Snowden    513-423-0504   
Principal Investigator: Nandagopal S Vrindavanam, MD         
Sponsors and Collaborators
Cahaba Pharmaceuticals
Principal Investigator: James Cantrell, MD Birmingham Hematology/Oncology Associates

Responsible Party: James Cantrell, MD, Birmingham Hematology/Oncology Associates LLC Identifier: NCT01100463     History of Changes
Other Study ID Numbers: OIC-1UO-C001
First Posted: April 9, 2010    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2010

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