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Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome

Primary Purpose

Palmar-Plantar Erythrodysesthesia, Breast Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cream

0.1% Uracil Cream

About this trial

This is an interventional prevention trial for Palmar-Plantar Erythrodysesthesia focused on measuring HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Bruno Cancer Center
Comprehensive Cancer Center
Research Institute of Deaconess Clinic
Cancer Care Center
Kansas City Cancer Centers
Signal Point Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo Lotion

0.1% Uracil

Arm Description

Outcomes

Primary Outcome Measures

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

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

Pharmacokinetic levels will be drawn at specific intervals

Secondary Outcome Measures

Anti-Tumor efficacy of Capecitabine

RECIST - Radiologic Criteria for subjects with measurable disease

Full Information

NCT ID

NCT01100463

First Posted

April 6, 2010

Last Updated

October 5, 2019

Sponsor

Nanometics (d.b.a. PHD Biosciences)

1. Study Identification

Unique Protocol Identification Number

NCT01100463

Brief Title

Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome

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 Topical Cream (UTC) in the Prevention of Hand-Foot Syndrome (HFS) in Patients With Metastatic Breast Cancer Treated With Capecitabine

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

April 2010 (Actual)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanometics (d.b.a. PHD Biosciences)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Palmar-Plantar Erythrodysesthesia, Breast Cancer

Keywords

HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo Lotion

Arm Type

Placebo Comparator

Arm Title

0.1% Uracil

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Cream

Intervention Description

Twice daily lotion to prevent HFS

Intervention Type

Drug

Intervention Name(s)

0.1% Uracil Cream

Intervention Description

Twice daily lotion to prevent HFS

Primary Outcome Measure Information:

Title

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

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

Time Frame

Maximum of 6 months of therapy

Title

Serum Pharmacokinetic Levels of Uracil will be drawn

Description

Pharmacokinetic levels will be drawn at specific intervals

Time Frame

Maximum of 6 months of therapy

Secondary Outcome Measure Information:

Title

Anti-Tumor efficacy of Capecitabine

Description

RECIST - Radiologic Criteria for subjects with measurable disease

Time Frame

Maximum of 6 months of therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Cantrell, MD

Organizational Affiliation

Birmingham Hematology/Oncology Associates

Official's Role

Principal Investigator

Facility Information:

Facility Name

Bruno Cancer Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Comprehensive Cancer Center

City

Palm Springs

State/Province

California

ZIP/Postal Code

92262

Country

United States

Facility Name

Research Institute of Deaconess Clinic

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47713

Country

United States

Facility Name

Cancer Care Center

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

Kansas City Cancer Centers

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66210

Country

United States

Facility Name

Signal Point Clinical Research Center

City

Middleton

State/Province

Ohio

ZIP/Postal Code

45042

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome

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