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 Objective:

To assess the safety and efficacy of karenitecin versus topotecan in 500 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.

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).

 

Protocol Number: KTN32313R

ClinicalTrials.gov identifier: NCT00477282