Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Caelyx

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring biweekly schedule of PLD - Ovarian cancer - pegylated liposomal doxorubicin -quality of life - Toxic skin reactions

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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: patients with more than 4 chemotherapies in medical history severe cardiac disease

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Caelyx

Arm Description

Outcomes

Primary Outcome Measures

Toxicity

Secondary Outcome Measures

Overall survival

Full Information

NCT ID

NCT00170573

First Posted

September 9, 2005

Last Updated

March 24, 2016

Sponsor

North Eastern German Society of Gynaecological Oncology

1. Study Identification

Unique Protocol Identification Number

NCT00170573

Brief Title

Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

October 2001 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

North Eastern German Society of Gynaecological Oncology

4. Oversight

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Cancer

Keywords

biweekly schedule of PLD - Ovarian cancer - pegylated liposomal doxorubicin -quality of life - Toxic skin reactions

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Caelyx

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Caelyx

Intervention Description

Caelyx 40 mg/ m2biweekly

Primary Outcome Measure Information:

Title

Toxicity

Time Frame

Toxicity

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

Overall survival

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jalid Sehouli

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Principal Investigator

Ovarian Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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