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.
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 spironolactone to prevent/attenuate rash from EGFR inhibitors. (Study II) SECONDARY OBJECTIVES: I. To explore efficacy of the spironolactone versus placebo. (Study I) II. To describe the efficacy of a Modified Preemptive Therapy Regimen intervention. (Study II) III. To explore the adverse event profile of spironolactone and the Modified Preemptive Therapy Regimen intervention. (Study II) IV. To explore patient reported outcomes of patients using spironolactone and a Modified Preemptive Therapy Regimen intervention. (Study II) V. To explore long term (8 week) effect of the 4 week treatment of spironolactone and a Modified Preemptive Therapy Regimen intervention on EFGR induced rash. (Study II) OUTLINE: STUDY I: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients apply spironolactone topically to face twice daily (BID) for 4 weeks. ARM II: Patients apply placebo topically to face BID for 4 weeks. STUDY II: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients apply spironolactone topically to face and body BID for 4 weeks ARM II: Patients undergo modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically before going outside, hydrocortisone topically once daily (QD), and doxycycline orally (PO) BID for 4 weeks. After completion of study, patients are followed up for 4 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
19
Given PO
Moisturizer given topically
Given topically
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
Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
Adverse events were collected at the end of one 4-week cycle and one 4-week observation period according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a grade 2+ adverse event attributed to spironolactone is reported here.
Time frame: At 8 weeks
Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)
Adverse events were collected at the end of each 4-week cycle according to the Common Terminology Criteria for Adverse Events (CTCAE) CTEP Version 4.0. The number of patients reporting a truncal/extremity adverse event is reported here. The treatment will be considered feasible if at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks.
Time frame: At 4 weeks
Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)
The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.
Time frame: At 4 weeks
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)
The primary analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 4. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 4 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.
Time frame: At 4 weeks
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Ancillary studies
Given topically
Given topically
Given topically
Marshfield Clinic
Marshfield, Wisconsin, United States
Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)
Patients will be dichotomously categorized as a success if no rash is reported and a failure if rash exists at the end of 4 weeks. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported.
Time frame: At 4 weeks
Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)
All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.
Time frame: At 4 weeks
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)
This analysis will be descriptive in nature, and will involve an intent-to-treat analysis at the end of week 8. Patients will be categorized dichotomously according to healthcare provider reported grade 2 or worse rash. The absence of any grade 2 or worse rash will be a success and the existence of any such rash will be a failure. Patients who do not complete the 8 week treatment will be considered a failure. Point estimates and 95% confidence limits will be calculated.
Time frame: At 8 weeks
Incidence of Healthcare Provider Reported Adverse Events (Study II)
All secondary endpoints will be reported descriptively using frequency statistics and single sample t-tests. Outcomes with respect to baseline covariates will also be explored.
Time frame: At 8 weeks
Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)
Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.
Time frame: At 4 weeks