Trial record 1 of 11 for:
Topotecan phase III | Ovarian Cancer | Germany
Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy
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| ClinicalTrials.gov Identifier: NCT00312988 |
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Recruitment Status :
Completed
First Posted : April 11, 2006
Last Update Posted : April 11, 2006
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Sponsor:
North Eastern German Society of Gynaecological Oncology
Information provided by:
North Eastern German Society of Gynaecological Oncology
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Ovarian cancer
MedlinePlus related topics:
Ovarian Cancer
Primary Outcome Measures :
- overall survival
Secondary Outcome Measures :
- time to progression
- determining adverse effects
- quality of life
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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 ClinicalTrials.gov identifier (NCT number): NCT00312988
Locations
| Germany | |
| Charité Campus Virchow-Klinikum | |
| Berlin, Germany, 13353 | |
Sponsors and Collaborators
North Eastern German Society of Gynaecological Oncology
Investigators
| Principal Investigator: | Jalid Sehouli | Charite University, Berlin, Germany |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov 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:
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Ovarian cancer |
Additional relevant MeSH terms:
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Ovarian Neoplasms Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Genital Neoplasms, Female Urogenital Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Topotecan Adnexal Diseases Genital Diseases, Female Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Genital Diseases Endocrine System Diseases Gonadal Disorders Carcinoma Gemcitabine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors |