Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

Ovarian Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170573
• Other study ID #: 32005000
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: March 24, 2016
• Start date: October 2001
• Est. completion date: August 2010

Study information

• Verified date: March 2016
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pegylated liposomal doxorubicin (PLD) formulation has been approved for the treatment of recurrent ovarian cancer (ROC). Toxic skin reactions 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: August 2010
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Caelyx
Caelyx 40 mg/ m2biweekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity		Toxicity
Secondary	Overall survival		Overall survival