Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT00743431|
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : June 22, 2010
Last Update Posted : April 15, 2015
|Condition or disease||Intervention/treatment|
|Ovarian Neoplasms||Drug: Caelyx (Pegylated Lyposomal Doxorubicin)|
This observational program is aimed at gaining tolerability and safety data with the routine use of Caelyx in its labelled indication in ovarian cancer, focusing on infusion reaction and PPE.
Data will be raised about the premedication routinely used for the prevention of side effects caused by Caelyx. Premedications for infusion reactions include corticosteroids, serotonin 3 (5HT3) antagonists, histamine 1 (H1) blockers, and histamine 2 (H2) blockers. Premedications for PPE include oral dexamethasone and vitamin B6.
The management of infusion reactions and PPE will be recorded. A detailed record of the medical history may reveal patient groups at a higher risk of experiencing these side effects.
|Study Type :||Observational|
|Actual Enrollment :||224 participants|
|Official Title:||Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
U.S. FDA Resources
Women with advanced ovarian cancer
Drug: Caelyx (Pegylated Lyposomal Doxorubicin)
Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.
- Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) [ Time Frame: The observational program was conducted over a period of 2 years ]
Definitions in assessment of adverse event severity:
Mild: awareness of sign, symptom, or event, but easily
Moderate: discomfort enough to cause interference with usual
activity and may warrant intervention.
Severe: incapacitating with inability to do usual activities or
significantly affects clinical status, and warrants