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Trial record 27 of 115 for:    cancer | butyrate

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

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ClinicalTrials.gov Identifier: NCT01867294
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Academic and Community Cancer Research United

Brief 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.

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Dermatologic Complication Drug: Doxycycline Procedure: Management of Therapy Complications Other: Placebo Other: Questionnaire Administration Drug: Spironolactone Drug: Sunscreen Drug: Therapeutic Hydrocortisone Phase 2

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: 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
Actual Study Start Date : August 31, 2012
Actual Primary Completion Date : May 9, 2014
Actual Study Completion Date : June 13, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rashes

Arm Intervention/treatment
Experimental: Arm I (Study I)
Patients apply spironolactone topically to face BID for 4 weeks.
Other: Questionnaire Administration
Ancillary studies

Drug: Spironolactone
Given topically
Other Names:
  • 17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate
  • Aldactone
  • SC 9420
  • SPL

Experimental: Arm I (Study II)
Patients apply spironolactone topically to face and body BID for 4 weeks.
Other: Questionnaire Administration
Ancillary studies

Drug: Spironolactone
Given topically
Other Names:
  • 17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate
  • Aldactone
  • SC 9420
  • SPL

Placebo Comparator: Arm II (Study I)
Patients apply placebo topically to face BID for 4 weeks.
Other: Placebo
Given topically
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Other: Questionnaire Administration
Ancillary studies

Active Comparator: 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.
Drug: Doxycycline
Given PO
Other Name: Doxycycline Monohydrate

Procedure: Management of Therapy Complications
Moisturizer given topically

Other: Questionnaire Administration
Ancillary studies

Drug: Sunscreen
Given topically
Other Name: Sunblock

Drug: Therapeutic Hydrocortisone
Given topically
Other Names:
  • Aeroseb-HC
  • Barseb HC
  • Barseb-HC
  • Cetacort
  • Cort-Dome
  • Cortef
  • Cortenema
  • Cortifan
  • Cortisol
  • Cortispray
  • Cortril
  • Dermacort
  • Domolene
  • Eldecort
  • Hautosone
  • Heb-Cort
  • hydrocortisone
  • Hydrocortone
  • Hytone
  • Komed-HC
  • Nutracort
  • Proctocort
  • Rectoid




Primary Outcome Measures :
  1. 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) [ Time Frame: 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.

  2. Incidence of a grade 2+ adverse event attributed to spironolactone (Study I) [ Time Frame: At 8 weeks ]
    The treatment will be considered feasible if less than 20% of patients experience a grade 2+ adverse event attributed to spironolactone.

  3. Incidence of truncal/extremity rash of any grade in patients in the spironolactone arm (Study I) [ Time Frame: At 4 weeks ]
    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.

  4. Percentage of patients in the spironolactone arm who complete the 4-week study intervention (Study I) [ Time Frame: At 4 weeks ]
    Treatment will be considered feasible if at least 60% of patients complete study intervention.


Secondary Outcome Measures :
  1. Efficacy of spironolactone versus placebo measured by the use of the Brief Pictorial Rash Incidence Questionnaire (Study I) [ Time Frame: At 4 weeks ]
    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. Frequency statistics will be employed to determine the percent of patients receiving efficacious treatment. Point estimates and 95% confidence intervals will be calculated. The success rate will be used to further determine whether to proceed to stage 2.

  2. Efficacy of the Modified Preemptive Therapy Regimen, calculated and analyzed analogously to the efficacy of the spironolactone (Study II) [ Time Frame: At 4 weeks ]
    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.

  3. 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) [ Time Frame: At 8 weeks ]
    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.

  4. Incidence of healthcare provider reported adverse events (Study II) [ Time Frame: At 8 weeks ]
    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.

  5. Patient reported outcomes as measured by the change from baseline in the SKINDEX-16 total score (Study II) [ Time Frame: At 4 weeks ]
    Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01867294


Locations
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United States, Illinois
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Iowa
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States, 50309
United States, Kansas
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
United States, Minnesota
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States, 56303
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Academic and Community Cancer Research United
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Aminah Jatoi Academic and Community Cancer Research United

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Responsible Party: Academic and Community Cancer Research United
ClinicalTrials.gov Identifier: NCT01867294     History of Changes
Obsolete Identifiers: NCT02257086
Other Study ID Numbers: RC09C8
NCI-2012-01275 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
RC09C8 ( Other Identifier: Academic and Community Cancer Research United )
P30CA015083 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Neoplasms
Hydrocortisone 17-butyrate 21-propionate
Doxycycline
Hydrocortisone
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Cetuximab
Panitumumab
Spironolactone
Sunscreening Agents
Antineoplastic Agents, Immunological
Antineoplastic Agents
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Radiation-Protective Agents
Protective Agents
Dermatologic Agents