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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Palmar-Plantar Erythrodysesthesia, Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

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

Outcome Measure:

Incidence of Grade 2 and 3 HFS as graded by Roche Criteria

Outcome Description:

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

Outcome Time Frame:

Maximum of 6 months of therapy

Safety Issue:

Yes

Principal Investigator

James Cantrell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Birmingham Hematology/Oncology Associates

Authority:

United States: Food and Drug Administration

Study ID:

OIC-1UO-C001

NCT ID:

NCT01100463

Start Date:

December 2009

Completion Date:

December 2011

Related Keywords:

  • Palmar-Plantar Erythrodysesthesia
  • Breast Cancer
  • HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer
  • Breast Neoplasms

Name

Location

Cancer Care CenterNew Albany, Indiana  47150
Comprehensive Cancer CenterGlendale, California  91204
Kansas City Cancer CentersLenexa, Kansas  
Signal Point Clinical Research CenterMiddletown, Ohio  45042
Bruno Cancer CenterBirmingham, Alabama  35205
Research Institute of Deaconess ClinicEvansville, Indiana  47713