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

NCT00743431CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Merck Sharp & Dohme LLC

Enrollment

224

Start Date

2005-02-01

Completion Date

2008-12-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Caelyx (Pegylated Lyposomal Doxorubicin)

Conditions

Ovarian Neoplasms

Eligibility

Sex

FEMALE

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)

Outcome Measures

Primary Outcomes

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

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.

Time frame: The observational program was conducted over a period of 2 years

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

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