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NCT00312988 Clinical Trial

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

Ovarian Cancer Clinical Trial

Official title:
Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00312988
Other study ID # 031000
Secondary ID Topo Phase III
Status Completed
Phase Phase 3
First received September 9, 2005
Last updated April 10, 2006
Start date January 2000
Est. completion date December 2009

Study information
Verified date September 2005
Source North Eastern Germany Society of Gynaecologic Oncology
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 450
Est. completion date December 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Hycamtin

• Gemcitabine

Locations
Country Name City State
Germany Charité Campus Virchow-Klinikum Berlin

Sponsors (1)
Lead Sponsor Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival
Secondary time to progression
Secondary determining adverse effects
Secondary quality of life
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