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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 5
- 主要终点
- Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Arm I (Study I)
Patients apply spironolactone topically to face BID for 4 weeks.
干预措施: Questionnaire Administration (Other)
Arm I (Study I)
Patients apply spironolactone topically to face BID for 4 weeks.
干预措施: Spironolactone (Drug)
Arm I (Study II)
Patients apply spironolactone topically to face and body BID for 4 weeks.
干预措施: Questionnaire Administration (Other)
Arm I (Study II)
Patients apply spironolactone topically to face and body BID for 4 weeks.
干预措施: Spironolactone (Drug)
Arm II (Study I)
Patients apply placebo topically to face BID for 4 weeks.
干预措施: Placebo (Other)
Arm II (Study I)
Patients apply placebo topically to face BID for 4 weeks.
干预措施: Questionnaire Administration (Other)
Arm II (Study II)
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.
干预措施: Doxycycline (Drug)
Arm II (Study II)
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.
干预措施: Management of Therapy Complications (Procedure)
Arm II (Study II)
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.
干预措施: Questionnaire Administration (Other)
Arm II (Study II)
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.
干预措施: Sunscreen (Drug)
Arm II (Study II)
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.
干预措施: Therapeutic Hydrocortisone (Drug)
结局指标
主要结局
Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
时间窗: At 8 weeks
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.
Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)
时间窗: At 4 weeks
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.
Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)
时间窗: At 4 weeks
The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.
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)
时间窗: At 4 weeks
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.
次要结局
- Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)(At 4 weeks)
- Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)(At 4 weeks)
- 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)(At 8 weeks)
- Incidence of Healthcare Provider Reported Adverse Events (Study II)(At 8 weeks)
- Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)(At 4 weeks)