Status:
COMPLETED
Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil
Lead Sponsor:
Duke University
Conditions:
Hand Foot Syndrome
Palmar Plantar Erythrodysesthesia
Eligibility:
All Genders
18-90 years
Phase:
PHASE1
Brief Summary
Hand-foot syndrome (HFS), also known as palmar-plantar erythrodysethesia (PPE), occurs in a 25%-50% of patients treated with several commonly used anti-cancer drugs including capecitabine and sunitini...
Detailed Description
The primary objective is to evaluate whether topical sildenafil reduces the severity of hand foot syndrome or palmar plantar erythrodysesthesia (PPE) associated with sunitinib and capecitabine. The se...
Eligibility Criteria
Inclusion
- Subjects must meet the following criteria to be eligible for the study:
- Receiving capecitabine or sunitinib as part of routine standard care.
- CTCAE version 4.0, grade 1-3 PPE.
- Adults age ≥ 18
- Karnofsky (KPS) performance status of ≥70%
- Adequate organ and marrow function as defined below:
- \- ANC \> 1000/mL
- \- Platelets \> 75,000/mL
- \- Total bilirubin \< 1.5 x UNL
- \- AST(SGOT)/ALT(SGPT) \< 5 x UNL
- \- Creatinine Cr Cl est \> 40 mL/min (by Cockcroft-Gault)
- Not pregnant or lactating.
- Use of adequate birth control with female partners of male subjects agreeing to use a medically acceptable form of birth control: (1) surgical sterilization, (2) approved hormonal contraceptives (such as birth control pills or Depo-Provera), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, (4) an intrauterine device (IUD) or (5) post menopausal. Abstinence is not considered acceptable birth control. Postmenopausal woman must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Subjects meeting any of the following criteria are ineligible for study entry:
- Currently participating in a clinical trial.
- History of hypersensitivity or intolerance to sildenafil or other related products tadalafil (Cialis™), vardenafil (Levitra™) or poloxamer vehicle.
- Currently taking oral sildenafil or other related products tadalafil (Cialis™), vardenafil (Levitra™).
- Currently taking other treatment for PPE other than standard emollients.
- Using organic nitrates, either regularly and/or intermittently, in any form.
- History of myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
- Resting hypotension (BP \<90/50 mmHg) or hypertension (BP \>170/110 mmHg). Those subjects on alpha-blocker or anti-hypertensive therapy must be hemodynamically stable for at least two weeks before day 1 of study drug.
- Cardiac failure or coronary artery disease causing unstable angina.
- Known retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).
- Concomitant use of strong cytochrome P450 3A4 inducers or inhibitors (Ex: ketoconazole, itraconazole, erythromycin, saquinavir).
- Other acute or chronic inflammatory conditions or infections of the hands or feet that would complicate safety, application of topical creams, or study endpoints.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
- Pregnant or breast-feeding and/or lactating.
- Inability or unwillingness to comply with protocol.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01219023
Start Date
June 1 2010
End Date
April 1 2012
Last Update
October 30 2012
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710