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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
Not Enrolling
Female
Ovarian Neoplasms

Thank you

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 CenterNew York, New York  10016
The Sarah Cannon Cancer Center, Centennial Medical CenterNashville, Tennessee  37203