Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy
Information source: North Eastern Germany Society of Gynaecologic Oncology
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer
Intervention: Hycamtin (Drug); Gemcitabine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: North Eastern Germany Society of Gynaecologic Oncology Official(s) and/or principal investigator(s):
Jalid Sehouli, Principal Investigator, Affiliation: Charité Campus Virchow Klinikum
Summary
Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and
Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.
Clinical Details
Official title: Topotecan-Monotherapy Vs. Topotecan + Etoposide Vs. Topotecan + Gemcitabine in Therapy in Patients With Recurrent Ovarian Cancer
Study design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: overall survival
Secondary outcome: time to progressiondetermining adverse effects quality of life
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Charité Campus Virchow-Klinikum, Berlin 13353, Germany
Additional Information
Starting date: January 2000
Ending date: December 2009
Last updated: April 10, 2006
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