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

NCT01100463 | Completed Phase 1

• 1 other identifier: OIC-1UO-C001
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 6

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.

Conditions

Palmar-Plantar Erythrodysesthesia; Breast Cancer

Keywords

HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

  Maximum of 6 months of therapy

• Serum Pharmacokinetic Levels of Uracil will be drawn

  Pharmacokinetic levels will be drawn at specific intervals

  Maximum of 6 months of therapy

Secondary Outcomes (1)

• Anti-Tumor efficacy of Capecitabine

  Maximum of 6 months of therapy

Study Arms (2)

Placebo Lotion

PLACEBO COMPARATOR

Drug: Cream

0.1% Uracil

EXPERIMENTAL

Drug: 0.1% Uracil Cream

Interventions

Cream DRUG

Twice daily lotion to prevent HFS

Placebo Lotion

0.1% Uracil Cream DRUG

Twice daily lotion to prevent HFS

0.1% Uracil

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanometics (d.b.a. PHD Biosciences): lead

Study Sites (6)

Bruno Cancer Center

Birmingham, Alabama, 35205, United States

Location

Comprehensive Cancer Center

Palm Springs, California, 92262, United States

Location

Research Institute of Deaconess Clinic

Evansville, Indiana, 47713, United States

Location

Cancer Care Center

New Albany, Indiana, 47150, United States

Location

Kansas City Cancer Centers

Overland Park, Kansas, 66210, United States

Location

Signal Point Clinical Research Center

Middleton, Ohio, 45042, United States

Location

MeSH Terms

Conditions

Hand-Foot Syndrome; Breast Neoplasms; Hyaline Fibromatosis Syndrome

Condition Hierarchy (Ancestors)

Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• James Cantrell, MD

  Birmingham Hematology/Oncology Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 9, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 8, 2019

Record last verified: 2019-10

Locations

US (6)