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Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

Primary Purpose

Ovarian Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Caelyx
Sponsored by
North Eastern German Society of Gynaecological Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    September 9, 2005
    Last Updated
    March 24, 2016
    Sponsor
    North Eastern German Society of Gynaecological Oncology
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    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

    12. IPD Sharing Statement

    Learn more about this trial

    Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

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