NCT01867294

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Academic and Community Cancer Research United · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Neoplasm
• Dermatologic Complication

Interventions

Type	Name	Description
DRUG	Doxycycline	Given PO
PROCEDURE	Management of Therapy Complications	Moisturizer given topically
OTHER	Placebo	Given topically
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Spironolactone	Given topically
DRUG	Sunscreen	Given topically
DRUG	Therapeutic Hydrocortisone	Given topically

Timeline

• Start date: 2012-08-31
• Primary completion: 2014-05-09
• Completion: 2014-06-13
• First posted: 2013-06-04
• Last updated: 2020-01-09
• Results posted: 2020-01-09

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study