| ID | Type | Description | Link |
|---|---|---|---|
| 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 | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Study I) | Experimental | Patients apply spironolactone topically to face BID for 4 weeks. |
|
| Arm I (Study II) | Experimental | Patients apply spironolactone topically to face and body BID for 4 weeks. |
|
| Arm II (Study I) | Placebo Comparator | Patients apply placebo topically to face BID for 4 weeks. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | At 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi | Academic and Community Cancer Research United | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carle Cancer Center | Urbana | Illinois | 61801 | United States | ||
| Iowa-Wide Oncology Research Coalition NCORP |
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Study II was never opened due to the accrual rate in Study I.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study I: Spironolactone | Patients apply spironolactone topically to face BID for 4 weeks. |
| FG001 | Study I: Placebo | Patients apply placebo topically to face BID for 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Management of Therapy Complications | Procedure | Moisturizer given topically |
|
| Placebo | Other | Given topically |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Spironolactone | Drug | Given topically |
|
|
| Sunscreen | Drug | Given topically |
|
|
| Therapeutic Hydrocortisone | Drug | Given topically |
|
|
| 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. | 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. | 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. | 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. | At 4 weeks |
| Des Moines |
| Iowa |
| 50309 |
| United States |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | United States |
| Coborn Cancer Center at Saint Cloud Hospital | Saint Cloud | Minnesota | 56303 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
| FG002 | Study II: Spironolactone | Patients apply spironolactone topically to face and body BID for 4 weeks. |
| FG003 | Study II: Modified Therapy | 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
All patients that were treated and eligible for endpoint analysis were include in baseline characteristics. One patient from Study I: Spironolactone and one from Study I: Placebo withdrew from study participation prior to receiving any study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Study I: Spironolactone | Patients apply spironolactone topically to face BID for 4 weeks. |
| BG001 | Study I: Placebo | Patients apply placebo topically to face BID for 4 weeks. |
| BG002 | Study II: Spironolactone | Patients apply spironolactone topically to face and body BID for 4 weeks. |
| BG003 | Study II: Modified Therapy | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All patients that began study treatment were included in this analysis. | Posted | Count of Participants | Participants | At 8 weeks |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | All patients that began protocol treatment are included in this endpoint. | Posted | Count of Participants | Participants | At 4 weeks |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | All patients that began Study I treatment were included in this endpoint. | Posted | Count of Participants | Participants | At 4 weeks |
| |||||||||||||||||||||||||||||||||||||
| Primary | 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. | Study II was not conducted. | Posted | At 4 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | All patients that began study treatment are included in this analysis. | Posted | Number | participants | At 4 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Study II was not conducted. | Posted | At 4 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Study II was not conducted. | Posted | At 8 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Study II was not conducted. | Posted | At 8 weeks |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Study II was not conducted. | Posted | At 4 weeks |
|
Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.
Adverse events were assessed after one 4 week cycle, and after one 4-week observation prior for a maximum of up to 8 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study I: Placebo | Patients apply placebo topically to face BID for 4 weeks. | 2 | 9 | 2 | 9 | 8 | 9 |
| EG001 | Study I: Spironolactone | .Patients apply spironolactone topically to face BID for 4 weeks. | 0 | 8 | 2 | 8 | 6 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Death NOS | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Hepatobiliary disorders - Other, specify | Hepatobiliary disorders | MedDRA 12 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Gastrointestinal stoma necrosis | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Intraoperative hemorrhage | Injury, poisoning and procedural complications | MedDRA 12 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Creatinine increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| INR increased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA 12 | Systematic Assessment |
| |
| Hearing impaired | Ear and labyrinth disorders | MedDRA 12 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 12 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| White blood cell decreased | Investigations | MedDRA 12 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 12 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aminah Jatoi, M.D. | Mayo Clinic | 507.284.1623 | jatoi.aminah@mayo.edu |
| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D013148 | Spironolactone |
| D000085 | Acetates |
| D013473 | Sunscreening Agents |
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D007783 | Lactones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D011837 | Radiation-Protective Agents |
| D020011 | Protective Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D003879 | Dermatologic Agents |
| D045506 | Therapeutic Uses |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D011282 | Pregnenediones |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
Not provided
Not provided
| Male |
|
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.
|
|
|
|
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. |
|
|
|
|
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. |
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|