Palmar-Plantar ErythrodysesthesiaPhase 1/2NCT01100463
Study of 0.1% Uracil Topical Cream (UTC) for the Prevention of Hand-Foot Syndrome
A Phase 1/2 study testing Cream and 0.1% Uracil Cream in people with Palmar-Plantar Erythrodysesthesia and Breast Cancer, run by Nanometics (d.b.a. PHD Biosciences) at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Palmar-Plantar Erythrodysesthesia, Breast Cancer
- What is being tested?
- Cream and 0.1% Uracil Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 6 sitesUnited States
- Study dates
- Apr 2010to Sep 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Bruno Cancer Center
Birmingham, Alabama, 35205
Research Institute of Deaconess Clinic
Evansville, Indiana, 47713
Signal Point Clinical Research Center
Middleton, Ohio, 45042
Cancer Care Center
New Albany, Indiana, 47150
Kansas City Cancer Centers
Overland Park, Kansas, 66210
Comprehensive Cancer Center
Palm Springs, California, 92262
About this study
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
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.
Read the 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.
- Conditions
- Palmar-Plantar Erythrodysesthesia, Breast Cancer
- Being tested
- Cream, 0.1% Uracil Cream
- Keywords
- HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer
- Medical subject headings
- Hand-Foot Syndrome, Breast Neoplasms, Hyaline Fibromatosis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CreamDrug
Twice daily lotion to prevent HFS
0.1% Uracil CreamDrug
Twice daily lotion to prevent HFS
| Study group | Role | What they receive |
|---|---|---|
| Placebo Lotion | Placebo comparator | Not described Receives: Drug: Cream |
| 0.1% Uracil | Experimental | Not described Receives: Drug: 0.1% Uracil Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Maximum of 6 months of therapy
Serum Pharmacokinetic Levels of Uracil will be drawn
Pharmacokinetic levels will be drawn at specific intervals
Measured: Maximum of 6 months of therapy
Secondary outcomes (1)
Anti-Tumor efficacy of Capecitabine
RECIST - Radiologic Criteria for subjects with measurable disease
Measured: Maximum of 6 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar-Plantar ErythrodysesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanometics (d.b.a. PHD Biosciences)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Cantrell, MD, Principal investigator, Birmingham Hematology/Oncology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01100463
- Sponsor's protocol ID
- OIC-1UO-C001
- Status last verified
- Oct 2019
- First submitted
- 6 Apr 2010
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01100463
- Acronym / sponsor ID
- OIC-1UO-C001
- Conditions
- Palmar-Plantar Erythrodysesthesia, Breast Cancer
- Keywords
- HFS, Hand-Foot Syndrome, Capecitabine, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Nanometics (d.b.a. PHD Biosciences)Industry (pharma, biotech, devices)
- Study start
- Apr 2010 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Lotion | Placebo comparator | Drug: Cream |
| 0.1% Uracil | Experimental | Drug: 0.1% Uracil Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CreamTwice daily lotion to prevent HFS | Drug | Placebo Lotion |
| 0.1% Uracil CreamTwice daily lotion to prevent HFS | Drug | 0.1% Uracil |
Primary outcome
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
Serum Pharmacokinetic Levels of Uracil will be drawn
Time frame: Maximum of 6 months of therapy
Pharmacokinetic levels will be drawn at specific intervals
1 secondary outcome
Anti-Tumor efficacy of Capecitabine
Time frame: Maximum of 6 months of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Cantrell, MD principal investigator
Birmingham Hematology/Oncology Associates
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cream and 0.1% Uracil Cream in people with Palmar-Plantar Erythrodysesthesia and Breast Cancer, run by Nanometics (d.b.a. PHD Biosciences) at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 2 and 3 HFS as graded by Roche Criteria (time frame: Maximum of 6 months of therapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2019.