Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743431
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : June 22, 2010
Last Update Posted : April 15, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Ovarian Neoplasms
Intervention: Drug: Caelyx (Pegylated Lyposomal Doxorubicin)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
Pegylated Lyposomal Doxorubicin 50 mg/m2 every 4 weeks for 6 cycles

Participant Flow:   Overall Study
    Pegylated Lyposomal Doxorubicin
STARTED   224 
Toxicity                6 
Tumor progression                56 
Withdrawal by Subject                13 
Death                9 
Reason for discontinuation not specified                29 
No documentation available                13 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
Pegylated Lyposomal Doxorubicin 50 mg/m2 every 4 weeks for 6 cycles

Baseline Measures
   Pegylated Lyposomal Doxorubicin 
Overall Participants Analyzed 
[Units: Participants]
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 62.4  (10.95) 
[1] Mean age was calculated for the Intent-to-Treat (ITT) population of 214.
[Units: Participants]
Female   224 
Male   0 
Region of Enrollment 
[Units: Participants]
Austria   224 

  Outcome Measures

1.  Primary:   Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)   [ Time Frame: The observational program was conducted over a period of 2 years ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.

Results Point of Contact:  
Name/Title: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.

Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00743431     History of Changes
Other Study ID Numbers: P04085
First Submitted: August 26, 2008
First Posted: August 28, 2008
Results First Submitted: May 21, 2010
Results First Posted: June 22, 2010
Last Update Posted: April 15, 2015