Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

• Sponsor: North Eastern German Society of Gynaecological Oncology (Other)
• Overall Status: Completed
• CT.gov ID: NCT00170573
• Collaborator: (none)
• Enrollment: 82
• Arm: 1
• Duration (Months): 106

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Drug: Caelyx	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Aug 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Caelyx	Drug: Caelyx; Caelyx 40 mg/ m2biweekly

Outcome Measures

Primary Outcome Measures

1. Toxicity [Toxicity]

Secondary Outcome Measures

1. Overall survival [Overall survival]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• North Eastern German Society of Gynaecological Oncology

Investigators

• Principal Investigator: Jalid Sehouli, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: North Eastern German Society of Gynaecological Oncology
• ClinicalTrials.gov Identifier: NCT00170573
• Other Study ID Numbers: 32005000
• First Posted: Sep 15, 2005
• Last Update Posted: Mar 25, 2016
• Last Verified: Mar 1, 2016

• Keywords provided by North Eastern German Society of Gynaecological Oncology: biweekly schedule of PLD - Ovarian cancer - pegylated liposomal doxorubicin -quality of life - Toxic skin reactions
• Additional relevant MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Liposomal doxorubicin

Study Results

No Results Posted as of Mar 25, 2016