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Caelyx Biweekly in Heavily Pretreated Patients With Relapsed Ovarian Cancer

NCT ID: NCT00170573

Last Updated: 2024-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2010-08-31

Brief Summary

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Effect of biweekly schedule of PLD on dose-limiting toxicity of PPE and patient's quality of life

Detailed Description

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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.

Conditions

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Ovarian Cancer

Keywords

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Pegylated liposomal doxorubicin PPE Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Caelyx

40 mg/m² biweekly

Group Type EXPERIMENTAL

Caelyx

Intervention Type DRUG

40 mg/m² biweekly

Interventions

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Caelyx

40 mg/m² biweekly

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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North Eastern German Society of Gynaecological Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jalid Sehouli

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Other Identifiers

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Noggo ov4

Identifier Type: -

Identifier Source: org_study_id