Breast CancerPhase 1NCT00827580
Eniluracil Hand Foot Syndrome
A Phase 1 study testing Eniluracil in people with Breast Cancer and Colon Cancer, run by West Virginia University at 1 site in United States.
Trial summary
A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colon Cancer
- What is being tested?
- Eniluracil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Sep 2009
- Phase
- Phase 1
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study ONLY if ALL of the following criteria apply:
- Signed written informed consent.
- Male or female, at least 18 years of age.
- Histologically or cytologically confirmed diagnosis of breast or colon cancer.
- Radiologically documented measurable disease
- Planned to receive capecitabine at 1000-1250 mg/m2 PO twice daily and has experienced grade 1 or greater HFS on a previous cycle of capecitabine.
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- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 at study entry.
- Adequate liver function with SGOT and SGPT < 2.5 times upper limits of normal.
- Adequate bone marrow function evidence by WBC > 2500/mm3, PMN >2000/mm3 and platelet count > 100,000/mm3.
- Adequate renal function with serum creatinine < 1.7 mg/dl.
- Recovery from relevant toxicity before study entry.
- Negative serum or urine pregnancy test within 7 days before study entry for women of childbearing potential. Effective contraception throughout the course of the study for both male and female subjects if the risk of conception exists.
Who cannot join
- A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
- Known DPD deficiency
- Any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry.
- History of brain metastases or spinal cord compression, unless irradiated at least 28 days before study entry and stable without steroid treatment for >28 days.
- Stroke, major surgery, or other major tissue injury within 30 days before study entry.
- Myocardial infarction within 12 months or uncontrolled congestive heart failure, angina, arrhythmias, or ECG abnormalities.
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- No concurrent or planned use of topical pharmaceuticals to the hands or feet other than Aquaphor®.
- No concurrent or planned use of cytotoxic drugs (other than capecitabine).
- No other dermatologic condition that may complicate evaluation of the study.
- Other uncontrolled serious chronic disease or conditions that in the investigator's opinion could render compliance or follow-up in the protocol problematic.
- Breast feeding or lactating.
- Unable to return at the regular required intervals for reassessment or study drug administration.
- Legal incapacity or limited legal capacity, unless authorization is granted by a legal guardian.
- Allergy to lanolin
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Trials Research Unit, West Virginia University
Morgantown, West Virginia, 226506
About this study
Official title: A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)
A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).
Read the detailed description
Primary Objectives
- To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
- To assess any eniluracil dose response relationship in prevention of HFS.
- To evaluate any potential toxicity of eniluracil ointment.
- Conditions
- Breast Cancer, Colon Cancer
- Being tested
- Eniluracil
- Keywords
- HFS, patients with breast or colon cancer receiving capecitabine
- Medical subject headings
- Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EniluracilDrug
| Study group | Role | What they receive |
|---|---|---|
| Eniluracil | Experimental | Not described Receives: Drug: Eniluracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William P. Petros, Pharm D, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827580
- Sponsor's protocol ID
- HS20667
- Status last verified
- May 2018
- First submitted
- 22 Jan 2009
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Eniluracil Containing Ointment for Prevention of Hand Foot Syndrome (HRS) Following Capecitabine (Xeloda)
- ClinicalTrials.gov ID
- NCT00827580
- Acronym / sponsor ID
- HS20667
- Conditions
- Breast Cancer, Colon Cancer
- Keywords
- HFS, patients with breast or colon cancer receiving capecitabine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jan 2009 (actual)
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 23 Jan 2009 (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.
A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).
Detailed description
Primary Objectives
- To estimate the frequency of HFS following treatment with capecitabine as modulated by the unilateral local application of eniluracil containing ointment.
- To assess any eniluracil dose response relationship in prevention of HFS.
- To evaluate any potential toxicity of eniluracil ointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eniluracil | Experimental | Drug: Eniluracil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A subject will be eligible for inclusion in this study ONLY if ALL of the following criteria apply:
- Signed written informed consent.
- Male or female, at least 18 years of age.
- Histologically or cytologically confirmed diagnosis of breast or colon cancer.
- Radiologically documented measurable disease
Key exclusion criteria (14 listed)
- A subject will not be eligible for inclusion in this study if ANY of the following criteria apply:
- Known DPD deficiency
- Any other investigational drug, chronic corticosteroids or radiation therapy within 28 days before study entry.
- History of brain metastases or spinal cord compression, unless irradiated at least 28 days before study entry and stable without steroid treatment for >28 days.
- Stroke, major surgery, or other major tissue injury within 30 days before study entry.
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 |
|---|---|---|
| Eniluracil | Drug | Eniluracil |
Primary outcome
the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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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.
William P. Petros, Pharm D principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eniluracil in people with Breast Cancer and Colon Cancer, run by West Virginia University at 1 site 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 12 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 was stopped early. Results are not available in the source record.
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?
the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.. 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 30 May 2018.