Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

North Eastern German Society of Gynaecological Oncology

Status and phase

Completed

Phase 2

Conditions

Ovarian Cancer

Treatments

Drug: Caelyx

Study type

Interventional

Funder types

Other

Identifiers

NCT00170573

Noggo ov4

Details and patient eligibility

About

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

Full 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.

Enrollment

77 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients ≥ 18 years of age
recurrent ovarian, peritoneal, or tubal cancer and prior treatment with platinum- and paclitaxel were eligible to this trial.
Eastern Cooperative Oncology Group (ECOG) performance status less than 3.
renal function (serum creatinine 1.25 times the upper limit of normal, glomerular filtration rate greater than 60 ml/min)
liver function (AST/ ALT three times the upper limit of normal, bilirubin concentrations 1.25 the upper limit of normal)
bone marrow function (neutrophil count greater than 1.5 x 109/l, and a platelet count greater than 100 x 109/l).

Exclusion criteria