Karenitecin Versus Topotecan in Patients With Advanced Epithelial Ovarian Cancer

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioNumerik Pharmaceuticals, Inc.
• Collaborator: Crown Bioscience
• Treatments: Camptothecin; Topotecan

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).