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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Dermatologic Complication; Advanced Malignant Neoplasm

Treatments: Drug: Spironolactone; Drug: Therapeutic Hydrocortisone; Other: Questionnaire Administration; Drug: Sunscreen; Other: Placebo; Procedure: Management of Therapy Complications; Drug: Doxycycline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01867294

P30CA015083 (U.S. NIH Grant/Contract)

RC09C8 (Other Identifier)

NCI-2012-01275 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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19 participants in 4 patient groups, including a placebo group

Arm I (Study I)

Experimental group

Description:

Patients apply spironolactone topically to face BID for 4 weeks.

Treatment:

Drug: Spironolactone

Other: Questionnaire Administration

Arm I (Study II)

Experimental group

Description:

Patients apply spironolactone topically to face and body BID for 4 weeks.

Treatment:

Drug: Spironolactone

Other: Questionnaire Administration

Arm II (Study I)

Placebo Comparator group

Description:

Patients apply placebo topically to face BID for 4 weeks.

Treatment:

Other: Placebo

Other: Questionnaire Administration

Arm II (Study II)

Active Comparator group

Description:

Patients receive modified preemptive therapy regimen consisting of skin moisturizer topically BID, sunscreen topically as needed, hydrocortisone topically QD, and doxycycline PO BID for 4 weeks.

Treatment:

Drug: Doxycycline

Drug: Sunscreen

Drug: Therapeutic Hydrocortisone

Procedure: Management of Therapy Complications

Other: Questionnaire Administration