Ovarian Cancer
Conditions
Keywords
Ovarian, Cancer, Advanced Ovarian Cancer
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.
Interventions
DRUGKarenitecin
Karenitecin 1.0mg/m2/day administered as a single daily IV infusion over 60 minutes for 5 consecutive days every 3 weeks (21 days)
DRUGTopotecan
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)
Sponsors
Crown Bioscience
BioNumerik Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | baseline to measured progressive disease |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | baseline to date of death from any cause |
| Incidence of Anemia | 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. |
| Incidence of Neutropenia | 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 |
| Incidence of Thrombocytopenia | 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 |
Countries
Hungary, Lithuania, Poland, Romania, Russia
Outcome results
None listed