Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

Phase 2

Completed

• Conditions: Ovarian Cancer
• Interventions: Drug: Caelyx

• Registration Number: NCT00170573
• Lead Sponsor: North Eastern German Society of Gynaecological Oncology

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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-15
• Primary Completion: 2009-04
• Study Completion: 2010-08
• Results First Submitted: 2016-10-04
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-27
• Last Update Submitted: 2024-11-27
• Results First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 77

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

• patients with more than 4 chemotherapies in medical history
• severe cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Caelyx	Caelyx	40 mg/m² biweekly

Primary Outcome Measures

Name	Time	Method
Occurrence of Palmar-plantar Erythrodysesthesia (PPE)	through study completion, an average of 18 months	The outcome will be measured by number of participants with reported skin toxicity PPE of CTC (Common Toxicity Criteria)-Grade I / II / III / IV.; Grade I - Dysesthesia/paraesthesia tingling of hands and feet; Grade II - Discomfort in holding objects and upon walking, painless swelling and erythema; Grade III - painful erythema and swelling of palms and soles, periungual erythema and swelling; Grade IV - Desquamation, ulceration, blistering, severe pain

Secondary Outcome Measures

Name	Time	Method
Overall Survival	for up to 3 years	Overall survival estimated by the Kaplan-Meier method