NCT00312988

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (planned)
• Sponsor: North Eastern German Society of Gynaecological Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Hycamtin
DRUG	Gemcitabine

Timeline

• Start date: 2000-01-01
• Completion: 2009-12-01
• First posted: 2006-04-11
• Last updated: 2006-04-11

Locations

1 site across 1 country: Germany