NCT00193388

Brief Summary

In this phase II trial, we will evaluate the weekly schedule of topotecan in the second-line treatment of patients with small cell lung cancer

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Sep 2002

Typical duration for phase_2 lung-cancer

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
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

July 28, 2010

Status Verified

July 1, 2010

Enrollment Period

2.3 years

First QC Date

September 12, 2005

Last Update Submit

July 27, 2010

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rate

Secondary Outcomes (3)

  • Median survival

  • 1-year survival

  • Symptomatic improvement

Interventions

TopotecanDRUG

Eligibility Criteria

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

You may qualify if:

  • To be included in this study, you must meet the following criteria:
  • Small Cell Lung cancer
  • Progression after one previous regimen
  • Measurable or evaluable disease
  • Able to perform activities of daily living with assistance
  • Adequate bone marrow, liver and kidney function
  • No more than three previous courses of radiation therapy
  • Accessible for treatment and follow up
  • Must give written informed consent prior to study entry

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Central nervous system involvement
  • Serious or active infection
  • Serious underlying medical condition
  • Other active neoplasms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Topotecan

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Anthony Greco, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

September 1, 2002

Primary Completion

December 1, 2004

Study Completion

February 1, 2007

Last Updated

July 28, 2010

Record last verified: 2010-07