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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
| City: |
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Voorhees |
| State: |
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New Jersey |
| Zip Code: |
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08043 |
| Conditions: |
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Ovarian Cancer |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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).
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| NCT ID: |
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NCT00477282 |
| Primary Contact: |
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Study Director (BioNumerik Pharmaceuticals Inc)
Phone: 210-614-1701
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| Backup Contact: |
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N/A |
| Location Contact: |
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Voorhees, New Jersey 08043
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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