Study of OSI-211 vs. Topotecan in Patients With Relapsed Epithelial Ovarian Cancer

Astellas

Status and phase: Completed; Phase 2

Conditions: Ovarian Neoplasms

Treatments: Drug: OSI-211 (Liposomal Lurtotecan)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00046800

110-20

Details and patient eligibility

About

The purpose of this study is to estimate the efficacy and safety of OSI-211 and topotecan in patients with relapsed epithelial ovarian cancer.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)