Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil (NCT01219023) | Clinical Trial Compass
CompletedPhase 1
Treatment of Palmar Plantar Erythrodysesthesia (PPE) With Topical Sildenafil
United States10 participantsStarted 2010-06
Plain-language 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 sunitinib. These drugs are known to improve survival in many cancers, including cancers of the colon, stomach, liver, breast, kidney, and GI stromal tumors (GIST). Worldwide, over 400,000 patients per year are treated with one of these agents. HFS involves skin changes, such as swelling, peeling, and blistering of the palms and soles, which is often painful and debilitating. As a result, HFS-related symptoms can frequently lead to dose reduction and/or discontinuation of otherwise effective anti-cancer treatment. There is no treatment for HFS other than dose reduction or stopping treatment. This proposal could quickly lead to treatments to prevent and/or treat HFS and help patients avoid debilitating side effects while continuing otherwise effective treatments for their cancer.
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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™).
What they're measuring
1
Grade of hand foot syndrome over time as measured by NCI CTC version 4.0 PPE syndrome criteria
Timeframe: Every 2 weeks (sunitinib arm); Every 3 weeks (capecitabine arm)
2
Assessment of patient reported pain, at rest and when making a fist, using a 1-10 score.
Timeframe: twice daily
3
Assessment of severity of erythema and desquamation or blistering as measured on 0-4 score from photographs.
Timeframe: Every 2 weeks (sunitinib arm); Every 3 weeks (capecitabine arm)
✕. 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.