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Trial record 1 of 11 for:    Topotecan phase III | Ovarian Cancer | Germany
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Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00312988
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : April 11, 2006
Information provided by:
North Eastern German Society of Gynaecological Oncology

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Hycamtin Drug: Gemcitabine Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer
Study Start Date : January 2000
Study Completion Date : December 2009

Primary Outcome Measures :
  1. overall survival

Secondary Outcome Measures :
  1. time to progression
  2. determining adverse effects
  3. quality of life

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00312988

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Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Sponsors and Collaborators
North Eastern German Society of Gynaecological Oncology
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Principal Investigator: Jalid Sehouli Charite University, Berlin, Germany
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00312988    
Other Study ID Numbers: 031000
Topo Phase III
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: April 11, 2006
Last Verified: September 2005
Keywords provided by North Eastern German Society of Gynaecological Oncology:
Ovarian cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases
Endocrine System Diseases
Gonadal Disorders
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors