Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab

Completed · Phase 2 · Has a placebo group

Conditions studied: Advanced Malignant Neoplasm, Dermatologic Complication

In brief

This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with cancer that has spread to other places in the body and are receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

Key facts

Study ID

NCT01867294

Run by

Academic and Community Cancer Research United

People needed

19

Starts

2012-08-31

Expected to finish

2014-06-13

Last updated by the study team

2020-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to start panitumumab or cetuximab; patients must not have been on the EGFR agent prior to randomization
• Ability to reliably apply topical spironolactone/placebo twice a day to the face
• Ability to complete questionnaire(s) by themselves or with assistance
• For study 2 only, patients must be willing to avoid sun exposure for one month from registration
• Creatinine =< 1.5 x upper limit of normal (UNL)
• For Study 2 only, ability to apply topical creams to the entire face and body

You may not qualify if…

• Prior allergic reaction or severe intolerance to spironolactone
• Any rash at the time of randomization
• Cutaneous metastases
• Any other disorder that may predispose to hyperkalemia in the opinion of the treating oncologist
• Use of topical corticosteroids at the time of study or their anticipated use in the next 8 weeks; (it is acknowledged that patients may be starting these agents pre-emptively as part of this protocol)
• For study 2 only, previous intolerance of sunscreen or any of the other components of the Modified Preemptive Therapy Regimen (a moisturizer or oral doxycycline)

Where it is running

• Carle Cancer Center — Urbana, Illinois, United States
• Iowa-Wide Oncology Research Coalition NCORP — Des Moines, Iowa, United States
• Cancer Center of Kansas - Wichita — Wichita, Kansas, United States
• Coborn Cancer Center at Saint Cloud Hospital — Saint Cloud, Minnesota, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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