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


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Principal Investigator

Jalid Sehouli

Investigator Role:

Principal Investigator

Investigator Affiliation:

Charité Campus Virchow Klinikum

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

031000

NCT ID:

NCT00312988

Start Date:

January 2000

Completion Date:

December 2009

Related Keywords:

  • Ovarian Cancer
  • Ovarian cancer
  • Ovarian Neoplasms

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