Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
NCT ID: NCT00477282
Last Updated: 2020-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
509 participants
INTERVENTIONAL
2007-08-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Karenitecin
Karenitecin
Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
Topotecan
Topotecan
Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days)
Interventions
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Karenitecin
Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
Topotecan
Topotecan 1.5 mg/m2/day administered as a single daily IV infusion over 30 minutes for 5 consecutive days every 3 weeks (21 days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of stage III or IV epithelial ovarian cancer
* Have cancer that is resistant to platinum/taxane-based chemotherapy regimens
* Have measurable, progressive disease
* Have an ECOG PS ≤ 2
Exclusion Criteria
* Have a life expectancy \< 3 months
* Received prior treatment with a camptothecin (topotecan, CPT-11, or investigational camptothecins).
* Received prior treatment with any platinum agent other than cisplatin or carboplatin.
* Received prior radiation therapy to greater than one-third of the hematopoietic sites (one-third of the pelvis and axial skeleton combined).
18 Years
FEMALE
No
Sponsors
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Crown Bioscience
INDUSTRY
BioNumerik Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Győr, , Hungary
Kaunas, , Lithuania
Klaipėda, , Lithuania
Elblag, , Poland
Krakow, , Poland
Lublin, , Poland
Olsztyn, , Poland
Oploe, , Poland
Poznan, , Poland
Poznan, , Poland
Szczecin, , Poland
Tarnów, , Poland
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Craiova, , Romania
Iași, , Romania
Oradea, , Romania
Sibiu, , Romania
Suceava County, , Romania
Târgu Mureş, , Romania
Ulan-Ude, Rep. of Buryatiya, Russia
Engel's, Saratov Oblast, Russia
Isvesk, Udmurtiya Republic, Russia
Arkhangelsk, , Russia
Birobidzhan, , Russia
Khabarovsk, , Russia
Krasnodar, , Russia
Kursk, , Russia
Magnitogorsk, , Russia
Nizhny Novgorod, , Russia
Novosibirsk, , Russia
Orenburg, , Russia
Petrozavodsk, , Russia
Pyatigorsk, , Russia
Ryazan, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Sochi, , Russia
Stavropol, , Russia
Syktyvkar, , Russia
Tambov, , Russia
Ufa, , Russia
Vladimir, , Russia
Vladivostok, , Russia
Countries
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Related Links
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MedlinePlus related topic: Ovarian Cancer
Other Identifiers
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KTN32313R
Identifier Type: -
Identifier Source: org_study_id
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