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

A Randomized, Open Label Phase II Study of OSI-211 vs Topotecan in Patients With Advanced and/or Recurrent Epithelial Ovarian Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00046800

Enrollment

Registered

2002-10-04

Start date

2002-09-30

Completion date

2003-03-31

Last updated

2011-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Neoplasms

Keywords

Ovarian Cancer

Brief summary

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

Interventions

DRUGOSI-211 (Liposomal Lurtotecan)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026