Advanced Malignant NeoplasmPhase 2NCT01867294
Spironolactone in Preventing Rash in Patients With Advanced Cancer Receiving Panitumumab and Cetuximab
A Phase 2 study testing Doxycycline, Management of Therapy Complications and Questionnaire Administration in people with Advanced Malignant Neoplasm and Dermatologic Complication, run by Academic and Community Cancer Research United at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Neoplasm, Dermatologic Complication
- What is being tested?
- Doxycycline, Management of Therapy Complications and Questionnaire Administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 5 sitesUnited States
- Study dates
- 31 Aug 2012to 13 Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309
Marshfield Clinic
Marshfield, Wisconsin, 54449
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, 56303
Carle Cancer Center
Urbana, Illinois, 61801
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214
About this study
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
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Being tested
- Doxycycline, Management of Therapy Complications, Placebo, Questionnaire Administration, Spironolactone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
Also called Doxycycline Monohydrate
Given PO
Management of Therapy ComplicationsProcedure or surgery
Moisturizer given topically
PlaceboOther
Also called placebo therapy, PLCB, sham therapy
Given topically
Questionnaire AdministrationOther
Ancillary studies
SpironolactoneDrug
Also called 17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate, Aldactone, SC 9420, SPL
Given topically
SunscreenDrug
Also called Sunblock
Given topically
Therapeutic HydrocortisoneDrug
Also called Aeroseb-HC, Barseb HC, Barseb-HC, Cetacort
Given topically
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Study I) | Experimental | Patients apply spironolactone topically to face BID for 4 weeks. Receives: Other: Questionnaire Administration; Drug: Spironolactone |
| Arm I (Study II) | Experimental | Patients apply spironolactone topically to face and body BID for 4 weeks. Receives: Other: Questionnaire Administration; Drug: Spironolactone |
| Arm II (Study I) | Placebo comparator | Patients apply placebo topically to face BID for 4 weeks. Receives: Other: Placebo; Other: Questionnaire Administration |
| Arm II (Study II) | Active comparator | 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. Receives: Drug: Doxycycline; Procedure: Management of Therapy Complications; Other: Questionnaire Administration; Drug: Sunscreen; Drug: Therapeutic Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
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.
Measured: At 8 weeks
Incidence of Truncal/Extremity Rash of Any Grade in Patients in the Spironolactone Arm (Study I)
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.
Measured: At 4 weeks
Percentage of Patients in the Spironolactone Arm Who Complete the 4-week Study Intervention (Study I)
The number of patients able to complete the 4-week study intervention and the 4-week observation period are reported.
Measured: 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)
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.
Measured: At 4 weeks
Secondary outcomes (5)
Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)
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. The number of patients that successfully completed 4 weeks of treatment and reported no rash on the Brief Pictorial Rash Incidence Questionnaire are reported.
Measured: At 4 weeks
Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)
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.
Measured: 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)
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.
Measured: At 8 weeks
Incidence of Healthcare Provider Reported Adverse Events (Study II)
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.
Measured: At 8 weeks
Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)
Total scores from the SKINDEX-16 will be compared from baseline to week 4. Comparisons between treatment arms will be made by t-tests.
Measured: At 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2013 (estimated)
- Study start31 Aug 2012
- Primary completion9 May 2014
- Study completion13 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Malignant NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, Principal investigator, Academic and Community Cancer Research United
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01867294
- Sponsor's protocol ID
- RC09C8
- Other IDs
- NCI-2012-01275, RC09C8, P30CA015083
- Status last verified
- Jan 2018
- First submitted
- 27 Aug 2012
- Last updated
- 9 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01867294
- Acronym / sponsor ID
- RC09C8
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Aug 2012 (actual)
- Primary completion
- 9 May 2014 (actual)
- Study completion
- 13 Jun 2014 (actual)
- First posted
- 4 Jun 2013 (estimated)
- Results
- Posted 9 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm I (Study I) | Experimental | Other: Questionnaire Administration, Drug: SpironolactonePatients apply spironolactone topically to face BID for 4 weeks. |
| Arm I (Study II) | Experimental | Other: Questionnaire Administration, Drug: SpironolactonePatients apply spironolactone topically to face and body BID for 4 weeks. |
| Arm II (Study I) | Placebo comparator | Other: Placebo, Other: Questionnaire AdministrationPatients apply placebo topically to face BID for 4 weeks. |
| Arm II (Study II) | Active comparator | Drug: Doxycycline, Procedure: Management of Therapy Complications, Other: Questionnaire Administration, Drug: Sunscreen, Drug: Therapeutic HydrocortisonePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DoxycyclineAlso: Doxycycline MonohydrateGiven PO | Drug | Arm II (Study II) |
| Management of Therapy ComplicationsMoisturizer given topically | Procedure or surgery | Arm II (Study II) |
| PlaceboAlso: placebo therapy, PLCB, sham therapyGiven topically | Other | Arm II (Study I) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (Study I), Arm I (Study II), Arm II (Study I), Arm II (Study II) |
| SpironolactoneAlso: 17-Hydroxy-7alpha-mercapto-3-oxo-17alpha-pregn-4-ene-21-carboxylic Acid, gamma Lactone, Acetate, Aldactone, SC 9420, SPLGiven topically | Drug | Arm I (Study I), Arm I (Study II) |
| SunscreenAlso: SunblockGiven topically | Drug | Arm II (Study II) |
| Therapeutic HydrocortisoneAlso: Aeroseb-HC, Barseb HC, Barseb-HC, CetacortGiven topically | Drug | Arm II (Study II) |
Primary outcome
Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I)
Time frame: 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)
Time frame: 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)
Time frame: 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)
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.
5 secondary outcomes
Efficacy of Spironolactone and Placebo Measured by the Use of the Brief Pictorial Rash Incidence Questionnaire (Study I)
Time frame: At 4 weeks
Efficacy of the Modified Preemptive Therapy Regimen, Calculated and Analyzed Analogously to the Efficacy of the Spironolactone (Study II)
Time frame: 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)
Time frame: At 8 weeks
Incidence of Healthcare Provider Reported Adverse Events (Study II)
Time frame: At 8 weeks
Patient Reported Outcomes as Measured by the Change From Baseline in the SKINDEX-16 Total Score (Study II)
Time frame: At 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi principal investigator
Academic and Community Cancer Research United
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycycline, Management of Therapy Complications and Questionnaire Administration in people with Advanced Malignant Neoplasm and Dermatologic Complication, run by Academic and Community Cancer Research United at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Reporting a Grade 2+ Adverse Event Attributed to Spironolactone (Study I) (time frame: At 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.