Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer

NCT ID: NCT00170664

Last Updated: 2016-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-01-31

Study Completion Date

2004-09-30

Brief Summary

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The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-center phase II-trial was conducted.

Detailed Description

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Conditions

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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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Paclitaxel, Carboplatin

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Interventions

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Paclitaxel

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV
* life expectancy of more than three months
* ECOG performance status less than 3
* laboratory parameters within the normal range, including a glomerular filtration rate (GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver transaminases less than two times the normal levels, bilirubin concentrations below 1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater than 1,500/µl, and a platelet count greater than 100,000/µl.
* written informed consent

Exclusion Criteria

* suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease
* radiotherapy within 4 weeks for study entry
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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North Eastern German Society of Gynaecological Oncology

OTHER

Sponsor Role lead

Principal Investigators

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Werner Lichtenegger

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité Campus Virchow-Klinikum

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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020114

Identifier Type: -

Identifier Source: org_study_id

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