Status:
COMPLETED
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
Lead Sponsor:
Academic and Community Cancer Research United
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Advanced Malignant Neoplasm
Dermatologic Complication
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 cet...
Detailed Description
PRIMARY OBJECTIVES: I. To determine feasibility of the administration of topical spironolactone versus placebo in this patient population. (Study I) II. To further explore the efficacy of the topical...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
August 31 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2014
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01867294
Start Date
August 31 2012
End Date
June 13 2014
Last Update
January 9 2020
Active Locations (5)
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1
Carle Cancer Center
Urbana, Illinois, United States, 61801
2
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
3
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
4
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303