Topotecan Weekly Versus Topotecan Day 1-5 in Patient With Platin-resistant Ovarian Cancer

NCT ID: NCT00170677

Last Updated: 2014-05-14

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

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2013-01-31

Brief Summary

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Comparison of topotecan weekly vs. topotecan day 1-5. The compatibility and activity are to be examined.

Detailed Description

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Topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. Due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. None randomised study exists comparing a weekly topotecan application with an application on day 1-5. This study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type ACTIVE_COMPARATOR

Topotecan

Intervention Type DRUG

Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.

B

Group Type EXPERIMENTAL

Topotecan

Intervention Type DRUG

Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.

Interventions

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Topotecan

Topotecan 4,0 mg/m² administered in day 1, 8 und 15 as i.v. infusion for 30 minutes. A cycle lasts 28 days.

Intervention Type DRUG

Topotecan

Topotecan 1,25 mg/m²/day, day 1-5 as i.v. infusion of 30 minutes. Repeat after 21 day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with histologically-confirmed ovarian cancer
* relapse within 6 month after primary therapy
* primary therapy with platin and taxan
* ECOG 0-2
* \>= 18 years
* leukocytes \>= 3.000/ µl
* platelet \>= 100.000/ µl
* neutrophil \>= 1.500/ µl
* written informed consent

Exclusion Criteria

* earlier topotecan therapy
* simultaneous or planned radiotherapy
* secondary malignancy
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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Werner Lichtenegger

Role: STUDY_CHAIR

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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4401000

Identifier Type: -

Identifier Source: org_study_id

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