Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy

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

PHASE3

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2009-12-31

Brief Summary

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Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

Detailed Description

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In Germany ovarian cancer belongs to the most frequently forms of cancer in the female population. The prognosis for women with a platin refractory ovarian cancer is very bad. The median survival time amounts for less a year. Especially in this palliative situation therapies regarding efficacy as well as quality of life are needed. in Germany Topotecan is approved since 1996 for patients after previous treatment with platin, the rare non-hematological side-effects making it interesting for a palliative therapy. Since best results in a chemo-therapeutical treatment are commonly obtained with the combination of two or more cytostatic agents this study tests a Topotecan Monotherapy and two Topotecan combinations. Both combination agents show efficacy alone against solid cancer using from Topotecan different mechanism resulting in different main side effects. Total survival, remission rates, time ti progression and quality of life are the main criteria investigated.

Conditions

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Ovarian Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Hycamtin

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patient with recurrent ovarian cancer
* Second-line chemotherapy
* \> = 18 years of age
* ECOG \< = 2

Exclusion Criteria

* ECOG \> 2
* Patients with more than one chemotherapy in anamneses

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Principal Investigators

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Jalid Sehouli

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

References

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Fotopoulou C, Karavas A, Trappe R, Chekerov R, Lichtenegger W, Sehouli J. Venous thromboembolism in recurrent ovarian cancer-patients: A systematic evaluation of the North-Eastern German Society of Gynaecologic Oncology Ovarian Cancer Study Group (NOGGO). Thromb Res. 2009 Nov;124(5):531-5. doi: 10.1016/j.thromres.2009.03.013. Epub 2009 May 8.

Reference Type DERIVED

PMID: 19427025 (View on PubMed)

Other Identifiers

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Topo Phase III

Identifier Type: -

Identifier Source: secondary_id

031000