NCT00743431

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

Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 224 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Neoplasms

Interventions

Type	Name	Description
DRUG	Caelyx (Pegylated Lyposomal Doxorubicin)	Pegylated Lyposomal Doxorubicin, 50 mg/m2 every 4 weeks for 6 cycles.

Timeline

• Start date: 2005-02-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-08-28
• Last updated: 2015-04-15
• Results posted: 2010-06-22