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

Information source: Academic and Community Cancer Research United
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dermatologic Complications; Malignant Neoplasm

Intervention: spironolactone (Drug); placebo (Other); questionnaire administration (Other); sunscreen (Drug); management of therapy complications (Procedure); doxycycline (Drug); therapeutic hydrocortisone (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Academic and Community Cancer Research United

Official(s) and/or principal investigator(s):
Aminah Jatoi, Principal Investigator, Affiliation: Academic and Community Cancer Research United

Summary

This randomized phase II trial studies how well giving spironolactone works in preventing rash in patients with advanced cancer receiving panitumumab and cetuximab. Spironolactone may prevent endothelial growth factor receptor (EGFR) inhibitor-induced skin rash.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Primary outcome:

Percentage of patients in the spironolactone arm who complete the 4-week study intervention (Study I)

Incidence of truncal/extremity rash of any grade in patients in the spironolactone arm (Study I)

Incidence of a grade 2+ adverse event attributed to spironolactone (Study I)

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 outcome:

Efficacy of spironolactone versus placebo measured by the use of the Brief Pictorial Rash Incidence Questionnaire (Study I)

Efficacy of the Modified Preemptive Therapy Regimen, calculated and analyzed analogously to the efficacy of the spironolactone (Study II)

Incidence of healthcare provider reported adverse events(Study II)

Patient reported outcomes (Study II)

Long-term effect on EFGR induced rash (Study II)

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

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)

Locations and Contacts

Mayo Clinic Hospital, Phoenix, Arizona 85054, United States
Additional Information

Starting date: August 2012
Last updated: March 11, 2015

Page last updated: August 23, 2015

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