Phase 2
N=19
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
Advanced Malignant Neoplasm · Dermatologic Complication
Bottom Line
View on ClinicalTrials.gov: NCT01867294 ↗Enrolled (actual)
19
Serious AEs
23.5%
Results posted
Jan 2020
Primary outcome: Primary: Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I) — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Doxycycline (Drug); Management of Therapy Complications (Procedure); Placebo (Other); Questionnaire Administration (Other); Spironolactone (Drug); Sunscreen (Drug); Therapeutic Hydrocortisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Academic and Community Cancer Research United
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I) |
0; 0 | — |
| PRIMARY Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I) |
6; 6 | — |
| PRIMARY Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I) |
4; 0 | — |
| PRIMARY Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II) |
— | — |
| SECONDARY Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I) |
1; 2 | — |
| SECONDARY Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II) |
— | — |
| SECONDARY Efficacy of the Spironolactone Treatment to Prevent/Attenuate Rash From EGFR Inhibitors in This Patient Population Defined as Absence of Any Grade 2 or Worse Rash (Study II) |
— | — |
| SECONDARY Incidence of Healthcare Provider Reported Adverse Events (Study II) |
— | — |
| SECONDARY Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II) |
— | — |
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 cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01867294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.