A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms
Female
Ovarian Neoplasms
Trial Information
A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer
Inclusion Criteria:
- Confirmed relapsed ovarian cancer.
- Measurable disease greater than or equal to 20 mm (or greater than or equal to 10 mm
on spiral CT scan).
- One or two prior regimens of chemotherapy. At least one regimen must have contained
cisplatin or carboplatin.
- At least three weeks since prior chemotherapy and recovery from any related
toxicities.
- At least four weeks since prior radiotherapy and recovery from any related
toxicities.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Authority:
United States: Food and Drug Administration
Study ID:
110-20
NCT ID:
NCT00046800
Start Date:
September 2002
Completion Date:
March 2003
Related Keywords:
- Ovarian Neoplasms
- Ovarian Cancer
- Neoplasms
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|---|
| NYU- Kaplan Comprehensive Cancer Center | New York, New York 10016 |
| The Sarah Cannon Cancer Center, Centennial Medical Center | Nashville, Tennessee 37203 |
