Clinical trial NCT00477282: Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer
Official title: A Phase 3 Study of Safety and Efficacy of Karenitecin Versus Topotecan Administered for 5 Consecutive Days Every 3 Weeks in Patients With Advanced Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Keywords: Ovarian
Cancer
Advanced Ovarian Cancer
Lead sponsor: BioNumerik Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Crown Bioscience
First posted: 2007-05-23
Enrollment: 509
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the safety and efficacy of karenitecin versus topotecan in patients with platinum/taxane-resistant advanced epithelial ovarian cancer. Additionally, this study will assess the ability of karenitecin to extend the time to disease progression, extend the overall survival time, and reduce the incidence and severity of treatment related hematological toxicities in patients with advanced epithelial ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* 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 uncontrolled high blood pressure, uncontrolled diabetes mellitus, or other serious underlying medical condition not compatible with study entry.
* 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).

Primary outcomes:
measure: Progression Free Survival
timeFrame: baseline to measured progressive disease
Secondary outcomes:
measure: Overall Survival
timeFrame: baseline to date of death from any cause
measure: Incidence of Anemia
timeFrame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration.
measure: Incidence of Neutropenia
timeFrame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration
measure: Incidence of Thrombocytopenia
timeFrame: Active treatment period (SAEs and on-going treatment-related AEs at end of treatment will be followed until resolution. All other AEs will be followed for up to 30 days after last treatment administration
Other outcomes:
Locations:
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Gyor
country: Hungary
city: Kaunas
country: Lithuania
city: Klaipeda
country: Lithuania
city: Elblag
country: Poland
city: Krakow
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Oploe
country: Poland
city: Poznan
country: Poland
city: Poznan
country: Poland
city: Szczecin
country: Poland
city: Tarnow
country: Poland
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj Napoca
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Oradea
country: Romania
city: Sibiu
country: Romania
city: Suceava County
country: Romania
city: Targu Mures
country: Romania
city: Ulan-Ude
country: Russian Federation
state: Rep. Of Buryatiya
city: Isvesk
country: Russian Federation
state: Republic Of Udmurtia
city: Engels
country: Russian Federation
state: Saratov Region
city: Arkhangelsk
country: Russian Federation
city: Birobidjan
country: Russian Federation
city: Khabarovsk
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Kursk
country: Russian Federation
city: Magnitogorsk
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Orenburg
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Sochi
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Syktyvkar
country: Russian Federation
city: Tambov
country: Russian Federation
city: Ufa
country: Russian Federation
city: Vladimir
country: Russian Federation
city: Vladivostok
country: Russian Federation
Study officials:
References: