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

NCT01867294 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-01-09

Study results available
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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.

Conditions

  • Advanced Malignant Neoplasm
  • Dermatologic Complication

Interventions

DRUG

Doxycycline

Given PO

PROCEDURE

Management of Therapy Complications

Moisturizer given topically

OTHER

Placebo

Given topically

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Spironolactone

Given topically

DRUG

Sunscreen

Given topically

DRUG

Therapeutic Hydrocortisone

Given topically

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Academic and Community Cancer Research United

    lead OTHER

Principal Investigators

  • Aminah Jatoi · Academic and Community Cancer Research United

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-05-09
Completion
2014-06-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01867294 on ClinicalTrials.gov