Clinical trial · Observational
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (Study P04085)(COMPLETED)
Caelyx in Ovarian Cancer: Prevention and Treatment of Infusion Reactions and Palmar-plantar Erythrodysesthesia (PPE).
NCT00743431CI-TRIAL-00017528completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Neoplasms | Ovarian Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Caelyx (Pegylated Lyposomal Doxorubicin) | Drug | Doxorubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Women with advanced ovarian cancer
- interventionNames
- Drug: Caelyx (Pegylated Lyposomal Doxorubicin)
Primary outcomes (1)
- measure
- Occurrences of Infusion Reactions and Palmar-Plantar Erythrodysesthesia (PPE)
- timeFrame
- The observational program was conducted over a period of 2 years
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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)
References
Publications (1)
- RESULTSteppan I, Reimer D, Sevelda U, Ulmer H, Marth C, Zeimet AG. Treatment of recurrent platinum-resistant ovarian cancer with pegylated liposomal doxorubicin--an evaluation of the therapeutic index with special emphasis on cardiac toxicity. Chemotherapy. 2009;55(6):391-8. doi: 10.1159/000262452. Epub 2009 Nov 30. PMID 19955744