TerminatedPhase 1

Eniluracil Hand Foot Syndrome

United States3 participantsStarted 2009-01

Plain-language summary

A pilot study of eniluracil containing ointment for prevention of hand foot syndrome (HRS) following capecitabine (Xeloda).

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.
✕. 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.

the frequency of HFS; evaluation of eniluracil dose response; and assessment of any toxicity related to the topical product.

NCT IDNCT00827580

SponsorWest Virginia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-09

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.
✓. 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.

✕. 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.
✕. 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.