Clinical trial NCT01867294: Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
Official title: A Two-Part, Phase II Randomized Trial to Explore Topical Spironolactone to Prevent/Attenuate Rash From Epidermal Growth Factor Receptor Inhibitors (Panitumumab and Cetuximab) in Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Malignant Neoplasm
Dermatologic Complication
Lead sponsor: Academic and Community Cancer Research United
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-04
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

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 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.

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)

Primary outcomes:
measure: Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
timeFrame: At 8 weeks
measure: Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)
timeFrame: At 4 weeks
measure: Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)
timeFrame: At 4 weeks
measure: 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)
timeFrame: At 4 weeks
Secondary outcomes:
measure: Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)
timeFrame: At 4 weeks
measure: Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)
timeFrame: At 4 weeks
measure: 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)
timeFrame: At 8 weeks
measure: Incidence of Healthcare Provider Reported Adverse Events (Study II)
timeFrame: At 8 weeks
measure: Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)
timeFrame: At 4 weeks
Other outcomes:
Locations:
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Des Moines
country: United States
facility: Iowa-Wide Oncology Research Coalition NCORP
state: Iowa
city: Wichita
country: United States
facility: Cancer Center of Kansas - Wichita
state: Kansas
city: Saint Cloud
country: United States
facility: Coborn Cancer Center at Saint Cloud Hospital
state: Minnesota
city: Marshfield
country: United States
facility: Marshfield Clinic
state: Wisconsin
Study officials:
affiliation: Academic and Community Cancer Research United
name: Aminah Jatoi
role: PRINCIPAL_INVESTIGATOR
References: