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

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Ovarian Neoplasms

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Trial Information

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

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

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)

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)

Outcome Description:

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.

Outcome Time Frame:

The observational program was conducted over a period of 2 years

Safety Issue:



Austria: Agency for Health and Food Safety

Study ID:




Start Date:

February 2005

Completion Date:

December 2008

Related Keywords:

  • Ovarian Neoplasms
  • Neoplasms
  • Ovarian Neoplasms