N/A
Completed N=224
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
Source: ClinicalTrials.gov NCT00743431 ↗Enrolled (actual)
224
Serious AEs
6.5%
Results posted
Jun 2010
Primary outcomePrimary: Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) — 2; 5; 2; 1 Events
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE) |
2; 5; 2; 1; 37; 23 | — |
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00743431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.