Conditions: Ovarian Cancer
Keywords: Pegylated liposomal doxorubicin PPE Ovarian Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 77
Healthy volunteers: no

Brief summary:
Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life

Detailed description:
Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions e.g. palmar-plantar erythrodysesthesia (PPE) were reported as being the dose-limiting toxicity and have an impact on patients' quality of life (QoL). The primary aim of this study was to optimise the toxicity profile by choosing a biweekly schedule of PLD Furthermore, QoL was investigated. Secondary objective of this study was to evaluate the response rates of this new regimen.

Arms:
arm 1: 40 mg/m² biweekly

Interventions: intervention 1: Caelyx
Intervention descriptions: intervention 1: 40 mg/m² biweekly

Protocol document: