Overview

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

Status:
Completed

Trial end date:
2014-06-13

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Academic and Community Cancer Research United

Collaborator:

National Cancer Institute (NCI)

Treatments:

Cetuximab
Cortisol succinate
Doxycycline
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Spironolactone
Sunscreening Agents

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)

- 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)