Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

BioNumerik Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Ovarian Cancer

Treatments

Drug: Karenitecin

Drug: Topotecan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00477282

KTN32313R

Details and patient eligibility

About

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.

Enrollment

509 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).