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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Cahaba Pharmaceuticals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Cahaba Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01100463
First received: April 6, 2010
Last updated: April 8, 2010
Last verified: April 2010
  Purpose

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01100463

Contacts
Contact: Michael R Myers, BA, MA 410-889-2221 mmyers@rpsweb.com
Contact: Joi Stone 866-877-7376 ext 3710 jstone@rpsweb.com

Locations
United States, Alabama
Bruno Cancer Center Recruiting
Birmingham, Alabama, United States, 35205
Contact: Brittany White    205-939-7880    Brittany.White@bhoallc.com   
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    ssagle@aptiumoncology.com   
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    louann_shoaff@deaconess.com   
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    cathy.wight@usoncology.com   
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    hasnowden@swohio.twcbc.com   
Principal Investigator: Nandagopal S Vrindavanam, MD         
Sponsors and Collaborators
Cahaba Pharmaceuticals
Investigators
Principal Investigator: James Cantrell, MD Birmingham Hematology/Oncology Associates
  More Information

No publications provided

Responsible Party: James Cantrell, MD, Birmingham Hematology/Oncology Associates LLC
ClinicalTrials.gov 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
Syndrome
Breast Diseases
Chemically-Induced Disorders
Dermatitis
Disease
Drug Eruptions
Drug Hypersensitivity
Drug-Related Side Effects and Adverse Reactions
Neoplasms
Neoplasms by Site
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014