Trial Outcomes & Findings for A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020) (NCT NCT00746694)
NCT ID: NCT00746694
Last Updated: 2015-08-27
Results Overview
Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it.
Recruitment status
COMPLETED
Target enrollment
154 participants
Primary outcome timeframe
Participants will do a single visit, but cases will be collected during a period of 12 months.
Results posted on
2015-08-27
Participant Flow
Participant milestones
| Measure |
Caelyx
Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
|
|---|---|
|
Overall Study
STARTED
|
154
|
|
Overall Study
COMPLETED
|
154
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Determine the Management of Palmar-plantar Erythrodysesthesia (PPE) in Patients With Metastatic Ovarian or Breast Cancer Treated With Caelyx (Study P05020)
Baseline characteristics by cohort
| Measure |
Caelyx
n=154 Participants
Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
|
|---|---|
|
Age, Continuous
|
62.4 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
154 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will do a single visit, but cases will be collected during a period of 12 months.Participants treated with Caelyx who developed PPE and the categories of specific treatment strategies that were prescribed to manage the symptoms of PPE. Participants counted under the strategies: Keep Skin Hydrated; Avoid Sweating and Physical Activity; Avoid Tight-Fitting Clothing; Local Cooling of Hands and Feet; were those who either always or sometimes followed it.
Outcome measures
| Measure |
Caelyx
n=154 Participants
Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
|
|---|---|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Avoid Tight-Fitting Clothing
|
14 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Local Cooling of Hands and Feet
|
13 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Oral Dexamethosone
|
10 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Pyridoxine
|
8 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Topical Corticosteroids
|
8 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Topical Dimethyl Sulfoxide
|
3 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Intravenous Dexamethasone
|
1 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Prostaglandins
|
1 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Avoid Excessive Heat/Water
|
14 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Keep Skin Hydrated
|
14 Participants
|
|
Number of Participants Who Received Concomitant Treatment Strategies to Manage Palmar-Plantar Erythrodysesthesia (PPE)
Avoid Sweating and Physical Activity
|
14 Participants
|
PRIMARY outcome
Timeframe: Participants will do a single visit, but cases will be collected during a period of 12 months.The number of participants who were treated with Caelyx, and who received either prophylactic treatment alone, or curative treatment alone, or both prophylactic and curative treatment for PPE.
Outcome measures
| Measure |
Caelyx
n=154 Participants
Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
|
|---|---|
|
Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE
Curative Treatment
|
14 Participants
|
|
Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE
Prophylaxis
|
52 Participants
|
|
Number of Participants That Received Curative Treatment and/or Prophylaxis Treatment for PPE
Curative & Prophylactic Treatment
|
6 Participants
|
Adverse Events
Caelyx
Serious events: 3 serious events
Other events: 122 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Caelyx
n=154 participants at risk
Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.65%
1/154 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.65%
1/154 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
2/154 • Number of events 2
|
Other adverse events
| Measure |
Caelyx
n=154 participants at risk
Caelyx, 2mg/ml concentrate for solution for intravenous (IV) administration. 50mg/m2 IV once every 4 weeks. Participants with metastatic breast or ovarian cancer treated with Caelyx as part of standard treatment.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
11.7%
18/154 • Number of events 18
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
11/154 • Number of events 11
|
|
Gastrointestinal disorders
Constipation
|
13.6%
21/154 • Number of events 21
|
|
Gastrointestinal disorders
Diarrhoea
|
13.6%
21/154 • Number of events 21
|
|
Gastrointestinal disorders
Nausea
|
33.1%
51/154 • Number of events 51
|
|
Gastrointestinal disorders
Stomatitis
|
44.2%
68/154 • Number of events 68
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
15/154 • Number of events 15
|
|
General disorders
Asthenia
|
39.6%
61/154 • Number of events 61
|
|
Metabolism and nutrition disorders
Anorexia
|
17.5%
27/154 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.6%
44/154 • Number of events 44
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Study data may be used in general publications or at conferences. Authorship will be attributed to those responsible for preparing the report and/or those who had a relevant part in designing the study. Whenever publication rules allow, all investigators will be listed individually. Investigators may publish their data individually. In this case investigators will notify the study sponsor, including the communication/manuscript to be published, at least 30 days before submission.
- Publication restrictions are in place
Restriction type: OTHER