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Trial record 90 of 2026 for:    doxil

Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059)

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ClinicalTrials.gov Identifier: NCT00604968
Recruitment Status : Terminated
First Posted : January 30, 2008
Results First Posted : May 2, 2011
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasms
Intervention Drug: Caelyx (pegylated liposomal doxorubicin; SCH 200746)
Enrollment 25
Recruitment Details  
Pre-assignment Details 28 patients were screened and 25 were enrolled. All 25 patients enrolled received >=1 cycle of treatment with Caelyx. Per protocol, treatment was to continue until progression, unacceptable toxicity, or other reason for discontinuation of treatment - all subjects eventually discontinued treatment but were considered to have completed the study.
Arm/Group Title Caelyx
Hide Arm/Group Description Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Period Title: Overall Study
Started 25
Completed 25 [1]
Not Completed 0
[1]
Due to the nature of study, all subjects receiving drug were considered to have completed.
Arm/Group Title Caelyx
Hide Arm/Group Description Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
0
   0.0%
>=65 years
25
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
72.3  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Time to Treatment Failure (Defined as Progression of Disease [According to the Response Evaluation Criteria in Solid Tumors (RECIST) or World Health Organization (WHO) Criteria] or Unacceptable Toxicity Leading to Discontinuation of Treatment or Death).
Hide Description Treatment failure was defined as progression of disease (according to the RECIST or WHO criteria) or unacceptable toxicity leading to discontinuation of treatment or death. Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease. Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.
Time Frame Time of treatment until progression of disease or unacceptable toxicity leading to discontinuation of treatment or death, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: Months
5.52
(3.67 to 8.52)
2.Secondary Outcome
Title Number of Patients With Stable Disease (SD) as Best Response
Hide Description

Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.

RECIST response criteria for SD required steady state of response of at least 9 weeks duration. There may be no appearance of new lesions.

WHO response criteria for SD required no significant change for at least 8 weeks.

Time Frame Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
Patients followed by RECIST only (n=10) 5
Patients followed by WHO only (n=4) 4
Patients followed by RECIST & WHO (n=8) 4
3.Secondary Outcome
Title Number of Patients With Partial Response (PR) as Best Response
Hide Description

Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.

RECIST PR criteria required >=30% decrease in certain target lesions & no increase in size of non-target lesions or appearance of new lesions

WHO PR criteria required partial decrease in size of lytic lesions, recalcification of lytic lesions, or decreased density of blastic lesions for >=4 wks

Time Frame Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
Patients followed by RECIST only (n=10) 1
Patients followed by WHO only (n=4) 0
Patients followed by RECIST & WHO (n=8) 2
4.Secondary Outcome
Title Number of Patients With Progressive Disease (PD) as Best Response
Hide Description

Response was calculated according to RECIST criteria except for bone metastasis where WHO criteria was used. For patients with skeletal disease only, WHO criteria was used. For patients with measurable disease according to RECIST as well as bone metastasis, both RECIST & WHO were used.

RECIST PD criteria required >=20% increase in certain target lesions OR progression of non-target lesions, or appearance of new lesions

WHO PD criteria required increase in size of existing lesions or appearance of new lesions.

Time Frame Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
10 patients were followed by RECIST, 4 patients were followed by WHO Response criteria, and 8 patients by both RECIST and WHO Response criteria (n=22). 3 patients had non-measurable disease and could not be included in the analysis.
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: participants
Patients followed by RECIST only (n=10) 4
Patients followed by WHO only (n=4) 0
Patients followed by RECIST & WHO (n=8) 2
5.Secondary Outcome
Title Number of Patients Requiring Dose Reduction
Hide Description The protocol contains instructions to reduce the Caelyx dose according to specific schedules, in cases necessary due to reasons such as hematological toxicity, non-hematological toxicity, cardiotoxicity, or other toxic side-effects of treatment reducing quality of life etc.
Time Frame Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
Due to weight change 6
Due to toxicity/adverse event 4
6.Secondary Outcome
Title Time to Response
Hide Description Response can be partial (>=30% decrease in the sum of Longest Diameter of target lesions, determined by two observations not less than 4 weeks apart; no unequivocal increase in the size of non-target lesions or the appearance of new lesions may occur) or complete (disappearance of all clinical evidence of tumor determined by 2 observations not less than 4 weeks apart), whichever status is recorded first.
Time Frame Time of treatment until response, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
Only 3 patients had measureable time to response
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: Weeks
Patient 1
12.2
(12.2 to 12.2)
Patient 2
11.4
(11.4 to 11.4)
Patient 3
12.0
(12.0 to 12.0)
7.Secondary Outcome
Title Duration of Response
Hide Description

Duration of response is defined as the time span from the first evaluation that shows response until the first evaluation that shows progression. Where patients did not show progress, duration of response was measured from the first evaluation that showed response until they discontinued the study.

Response can be partial or complete (as previously defined), whichever status is recorded first.

Time Frame Time of treatment until treatment discontinuation, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients showed Partial Response according to RECIST criteria.
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: weeks
Patient 1
11.8
(11.8 to 11.8)
Patient 2
48.6
(48.6 to 48.6)
Patient 3
17.8
(17.8 to 17.8)
8.Secondary Outcome
Title Time to Progression
Hide Description

Progression is defined as the first evaluation that shows progression (either by RECIST or WHO criteria):

Progressive Disease according to RECIST response criteria: >=20% increase in the sum of the Longest Diameter of target lesions or unequivocal progression of non-target lesions. Appearance of new lesions will also constitute progressive disease.

Progressive Disease according to WHO response criteria: Increase in size of existing lesions or appearance of new lesions.

Time Frame Time of treatment until progression, assessed every 12th week until end of treatment (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 25 patients in the study 3 patients had non-measurable disease and could not be included in the progression analysis.
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
5.69
(3.74 to 13.8)
9.Secondary Outcome
Title Duration of Overall Survival
Hide Description Patients were followed with regards to survival even after they left the trial (ie after End of Treatment visit). Deaths that occurred after patient participation ended were collected all the way through to the overall end of the trial which took place on Oct 31, 2009. These deaths were used to calculate overall survival.
Time Frame Time of treatment until death, up to the time that all participants ended treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: months
20.6
(6.58 to 25.6)
10.Secondary Outcome
Title Number of Days the Patients Were Hospitalized for Cancer-related Symptoms or Toxicity of Treatment
Hide Description The cumulative sum of hospitalization days during the study, per patient. Some patients had multiple hospitalizations.
Time Frame Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 25 total patients, 12 were hospitalized during the study.
Arm/Group Title Caelyx
Hide Arm/Group Description:
Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: days
Patient 1 1
Patient 2 1
Patient 3 6
Patient 4 4
Patient 5 5
Patient 6 71
Patient 7 16
Patient 8 1
Patient 9 1
Patient 10 3
Patient 11 33
Patient 12 20
Time Frame Time of treatment until treatment discontinuation (study planned to continue until all participants ended treatment).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Caelyx
Hide Arm/Group Description Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
All-Cause Mortality
Caelyx
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Caelyx
Affected / at Risk (%) # Events
Total   9/25 (36.00%)    
Cardiac disorders   
MYOCARDIAL INFARCTION  1  1/25 (4.00%)  1
Gastrointestinal disorders   
ABDOMINAL PAIN  1  1/25 (4.00%)  1
DYSPEPSIA  1  1/25 (4.00%)  1
VOMITING  1  1/25 (4.00%)  1
General disorders   
PYREXIA  1  2/25 (8.00%)  2
Infections and infestations   
CENTRAL LINE INFECTION  1  1/25 (4.00%)  1
CLOSTRIDIAL INFECTION  1  1/25 (4.00%)  1
CYSTITIS  1  1/25 (4.00%)  1
PNEUMONIA  1  1/25 (4.00%)  1
URINARY TRACT INFECTION  1  2/25 (8.00%)  2
Metabolism and nutrition disorders   
HYPOGLYCAEMIA  1  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
PULMONARY EMBOLISM  1  1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Caelyx
Affected / at Risk (%) # Events
Total   25/25 (100.00%)    
Blood and lymphatic system disorders   
ANAEMIA  1  4/25 (16.00%)  5
NEUTROPENIA  1  4/25 (16.00%)  7
Eye disorders   
DRY EYE  1  2/25 (8.00%)  2
LACRIMATION INCREASED  1  2/25 (8.00%)  2
Gastrointestinal disorders   
ABDOMINAL PAIN  1  3/25 (12.00%)  6
CONSTIPATION  1  6/25 (24.00%)  7
DIARRHOEA  1  6/25 (24.00%)  9
FLATULENCE  1  2/25 (8.00%)  2
GASTRITIS  1  2/25 (8.00%)  2
NAUSEA  1  16/25 (64.00%)  31
STOMATITIS  1  6/25 (24.00%)  15
VOMITING  1  7/25 (28.00%)  12
General disorders   
CHEST PAIN  1  3/25 (12.00%)  4
FATIGUE  1  17/25 (68.00%)  21
OEDEMA PERIPHERAL  1  4/25 (16.00%)  5
PYREXIA  1  6/25 (24.00%)  11
Investigations   
BLOOD ALKALINE PHOSPHATASE INCREASED  1  2/25 (8.00%)  2
BLOOD LACTATE DEHYDROGENASE INCREASED  1  3/25 (12.00%)  3
C-REACTIVE PROTEIN INCREASED  1  2/25 (8.00%)  4
HAEMOGLOBIN DECREASED  1  2/25 (8.00%)  2
WEIGHT DECREASED  1  3/25 (12.00%)  3
Metabolism and nutrition disorders   
DECREASED APPETITE  1  9/25 (36.00%)  9
Musculoskeletal and connective tissue disorders   
ARTHRALGIA  1  2/25 (8.00%)  2
BACK PAIN  1  6/25 (24.00%)  9
MUSCULOSKELETAL PAIN  1  4/25 (16.00%)  4
Nervous system disorders   
DIZZINESS  1  2/25 (8.00%)  2
HEADACHE  1  4/25 (16.00%)  4
Respiratory, thoracic and mediastinal disorders   
COUGH  1  3/25 (12.00%)  4
Skin and subcutaneous tissue disorders   
ALOPECIA  1  6/25 (24.00%)  6
BLISTER  1  4/25 (16.00%)  4
DRY SKIN  1  2/25 (8.00%)  2
ERYTHEMA  1  2/25 (8.00%)  3
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME  1  13/25 (52.00%)  18
RASH  1  4/25 (16.00%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If an investigator wishes to publish data from the study, a copy must be provided to the sponsor for review at least 60 days before submission for publication. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days. If issues arise regarding scientific integrity or regulatory compliance, the sponsor will review these issues with the investigator. The sponsor will not change scientific content or suppress information.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
EMail: ClinicalTrialsDisclosure@merck.com
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00604968     History of Changes
Other Study ID Numbers: P05059
First Submitted: January 21, 2008
First Posted: January 30, 2008
Results First Submitted: January 27, 2011
Results First Posted: May 2, 2011
Last Update Posted: June 7, 2017