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

This study has been completed.
Information provided by:
North Eastern Germany Society of Gynaecologic Oncology Identifier:
First received: September 9, 2005
Last updated: April 10, 2006
Last verified: September 2005

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

Condition Intervention Phase
Ovarian Cancer
Drug: Hycamtin
Drug: Gemcitabine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer

Resource links provided by NLM:

Further study details as provided by North Eastern Germany Society of Gynaecologic Oncology:

Primary Outcome Measures:
  • overall survival

Secondary Outcome Measures:
  • time to progression
  • determining adverse effects
  • quality of life

Estimated Enrollment: 450
Study Start Date: January 2000
Estimated Study Completion Date: December 2009
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00312988

Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Sponsors and Collaborators
North Eastern Germany Society of Gynaecologic Oncology
Principal Investigator: Jalid Sehouli Charité Campus Virchow Klinikum
  More Information

Additional Information:
No publications provided by North Eastern Germany Society of Gynaecologic Oncology

Additional publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00312988     History of Changes
Other Study ID Numbers: 031000, Topo Phase III
Study First Received: September 9, 2005
Last Updated: April 10, 2006
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by North Eastern Germany Society of Gynaecologic Oncology:
Ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders
Neoplasms by Site
Ovarian Diseases
Urogenital Neoplasms
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors processed this record on November 25, 2014