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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Ovarian Neoplasms

Treatments: Drug: Caelyx (Pegylated Lyposomal Doxorubicin)

Study type: Observational

Funder types: Industry

Identifiers

NCT00743431

P04085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: Female

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

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

Trial design

224 participants in 1 patient group

1

Description:

Women with advanced ovarian cancer

Treatment:

Drug: Caelyx (Pegylated Lyposomal Doxorubicin)