CompletedNot Applicable

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

224 participantsStarted 2005-02

Plain-language 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.

Who can participate

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

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

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

Trial details

NCT IDNCT00743431

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2008-12

Results submitted2010-05-21

View on ClinicalTrials.gov More Ovarian Neoplasms trials