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

Completed

• Conditions: Ovarian Neoplasms
• Interventions: Drug: Caelyx (Pegylated Lyposomal Doxorubicin)

• Registration Number: NCT00743431
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to evaluate the safety and tolerability of Caelyx in women with advanced ovarian cancer, focusing on infusion reactions and palmar-plantar erythrodysesthesia.

Detailed Description

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2008-08-26
• Study First Submitted QC: 2008-08-27
• Study First Posted: 2008-08-28
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Results First Submitted: 2010-05-21
• Results First Submitted QC: 2010-05-21
• Results First Posted: 2010-06-22
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 224

Inclusion Criteria

• Women with advanced ovarian cancer with:

  • previous platin/taxane therapy and documented measureable and/or evaluable advanced or metastatic cancer by radiological imaging or increase of serum cancer antigen 125 (CA 125) according to Rustin et al.

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Exclusion Criteria

• Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Caelyx (Pegylated Lyposomal Doxorubicin)	Women with advanced ovarian cancer

Primary Outcome Measures

Name	Time	Method
Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)	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; tolerated.; 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; intervention.