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| Sponsor: | North Eastern Germany Society of Gynaecologic Oncology |
|---|---|
| Information provided by: | North Eastern Germany Society of Gynaecologic Oncology |
| ClinicalTrials.gov Identifier: | NCT00312988 |
Purpose
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer |
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2000 |
| Estimated Study Completion Date: | December 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Charité Campus Virchow-Klinikum | |
| Berlin, Germany, 13353 | |
| Principal Investigator: | Jalid Sehouli | Charité Campus Virchow Klinikum |
More Information
| Study ID Numbers: | 031000, Topo Phase III |
| Study First Received: | September 9, 2005 |
| Last Updated: | April 10, 2006 |
| ClinicalTrials.gov Identifier: | NCT00312988 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Ovarian cancer |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses |
Gemcitabine Endocrine Gland Neoplasms Ovarian Neoplasms Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Adnexal Diseases Neoplasms Radiation-Sensitizing Agents Topotecan |
