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
18 Years
N/A
Both
Dermatologic Complications, Malignant Neoplasm
Trial Information
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
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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Feasibility of a topical spironolactone ointment at 4 weeks.
Outcome Description:
The primary analysis will influence the decision to proceed to the larger 60-patient trial and will depend on whether patients find the topical spironolactone tolerable with minimal side effects. The treatment will be considered feasible if: at least 60% of patients in the spironolactone arm complete the 4-week study intervention at least 50% of patients in the spironolactone arm develop a truncal/extremity rash of any grade at the end of 4 weeks. Again, the purpose of this assessment is to establish that the spironolactone is not causing any systemic anti-EGFR effects. less than 20% of patients experience a grade 2+ adverse event attributed to spironolactone
Outcome Time Frame:
4 weeks
Safety Issue:
No
Principal Investigator
Aminah Jatoi, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Academic and Community Cancer Research United
Authority:
United States: Food and Drug Administration
Study ID:
RC09C8
NCT ID:
NCT01867294
Start Date:
April 2013
Completion Date:
Related Keywords:
- Dermatologic Complications
- Malignant Neoplasm
- Neoplasms
Name | Location |
|---|---|
| Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
| Carle Foundation Hospital | Urbana, Illinois 61801 |
| Carle Cancer Center | Urbana, Illinois 61801 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| Carle Foundation Physician Services | Mattoon, Illinois 61938 |
| Carle Foundation Physician Group | Danville, Illinois 61832 |
