NCT00046800

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_2

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2002

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
Last Updated

October 20, 2011

Status Verified

October 1, 2011

First QC Date

October 3, 2002

Last Update Submit

October 18, 2011

Conditions

Ovarian Neoplasms

Keywords

Ovarian Cancer

Interventions

OSI-211 (Liposomal Lurtotecan)DRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

NYU- Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

The Sarah Cannon Cancer Center, Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

St Chad's Unit

Birmingham, B18 7QH, United Kingdom

Location

Beatson Oncology Centre

Glasgow, G11 6NT, United Kingdom

Location

Royal Surrey County Hospital

Guildford, Surrey, GU2 7XX, United Kingdom

Location

Royal Marsden NHS Trust

London, SW3 6JJ, United Kingdom

Location

Northern Centre for Cancer Research, Newcastle General Hospital

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

Mount Vernon Hospital

Northwood, Middlesex, HA6 2RN, United Kingdom

Location

CRC Department of Medical Oncology

Sutton Surrey, SM2 5PT, United Kingdom

Location

Taunton & Somerset Hospital

Taunton, TA1 5DA, United Kingdom

Location

Medical Oncology Unit, Torbay District General Hospital

Torquay, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

lurtotecan

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2002

First Posted

October 4, 2002

Study Start

September 1, 2002

Study Completion

March 1, 2003

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

GB(9)US(2)