Status:
COMPLETED
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
Brief 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 wi...
Eligibility Criteria
Inclusion
- 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
- Patients that are not treated according to the Austrian Summary of Product Characteristics (SPC)
Key Trial Info
Start Date :
February 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00743431
Start Date
February 1 2005
End Date
December 1 2008
Last Update
April 15 2015
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