NCT00046787

Brief Summary

The purpose of this study is to determine whether OSI-211 (Liposomal Lurtotecan) is an effective and safe treatment for patients with recurrent small cell lung cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Shorter than P25 for phase_2

Geographic Reach
2 countries

10 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
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 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

SCLCCarcinoma, Small Cell

Keywords

Small Cell Lung Cancer

Interventions

OSI-211 (Liposomal Lurtotecan)DRUG

Eligibility Criteria

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

You may qualify if:

  • Confirmed recurrent small cell lung cancer.
  • One prior treatment of chemotherapy.
  • At least three weeks since last chemotherapy treatment and recovery from any related side effects.
  • At least three weeks since last chest radiotherapy and at least 10 days since head irradiation and recovery from acute side effects.
  • At least one target tumor less than or equal to 20 mm (or less than or equal to 10 mm on spiral CT-scan).
  • If a patient has had previous documented Central Nervous System (CNS) involvement, only controlled disease is acceptable.

You may not qualify if:

  • Superior vena cava syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Arizona Clinical Research Center, Inc.

Tucson, Arizona, 85712, United States

Location

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

Baptist Hospital Regional Cancer Ctr.

Knoxville, Tennessee, 37920, United States

Location

Vanderbilt Clinical Trials Office

Nashville, Tennessee, 37232-6307, United States

Location

Nottingham City Hospital

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Clatterbridge Centre for Oncology

Bebington, Wirral, CH63 4JY, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, United Kingdom

Location

Guys Hospital

London, SE1, United Kingdom

Location

Christie Hospital

Manchester, M20 9BH, United Kingdom

Location

Northern Centre for Cancer Research, Newcastle General Hospital

Newcastle upon Tyne, NE4 6BE, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Small CellSmall Cell Lung Carcinoma

Interventions

lurtotecan

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
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

February 1, 2003

Last Updated

October 20, 2011

Record last verified: 2011-10

Locations

US(4)GB(6)