Skin and Connective Tissue Diseases

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Patients apply spironolactone topically to face BID for 4 weeks.

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

Patients apply placebo topically to face BID for 4 weeks.

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.

Management of Therapy Complications

Placebo

Questionnaire Administration

Sunscreen

Therapeutic Hydrocortisone

Aminah Jatoi

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.

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

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.

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.

The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.

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.

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.

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.

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.

Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.

National Cancer Institute (NCI)

Academic and Community Cancer Research United

Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.

Study I: Placebo

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

Study I: Spironolactone

Study II: Spironolactone

Study II: Modified Therapy

Total

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

All patients that were treated and eligible for endpoint analysis were include in baseline characteristics. One patient from Study I: Spironolactone and one from Study I: Placebo withdrew from study participation prior to receiving any study treatment.

Aminah Jatoi, M.D.

All patients that began study treatment were included in this analysis.

Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)

All patients that began protocol treatment are included in this endpoint.

Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)

All patients that began Study I treatment were included in this endpoint.

Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (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)

All patients that began study treatment are included in this analysis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	NCT01867294	Advanced Malign... Dermatologic Co...	Doxycycline Management of T... Placebo Questionnaire A... Spironolactone Sunscreen Therapeutic Hyd...	18 Years -	Academic and Community Cancer Research United
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab	NCT01867294	Advanced Malign... Dermatologic Co...	Doxycycline Management of T... Placebo Questionnaire A... Spironolactone Sunscreen Therapeutic Hyd...	18 Years -	Academic and Community Cancer Research United

Spots Global Cancer Trial Database for dermatologic complication