NCT00193401

Brief Summary

In this phase II trial, we will evaluate the weekly schedule of topotecan in the first-line treatment of elderly and/or poor performance status patients with extensive stage small cell lung cancer. Patients eligible for this trial will be those considered poor candidates for standard combination chemotherapy or other investigational regimens

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 lung-cancer

Timeline
Completed

Started Aug 2002

Shorter than P25 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

August 1, 2002

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2004

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
11 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
Last Updated

July 28, 2010

Status Verified

July 1, 2010

Enrollment Period

1.8 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 and 2 year survival

  • Overall toxicity

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:
  • Biopsy-proven small cell lung cancer, extensive stage disease
  • Age \> 65 years
  • No previous chemotherapy or radiation therapy.
  • Measurable or evaluable disease.
  • Adequate bone marrow, liver and kidney function.
  • Must be \> 4 weeks from previous major surgery
  • 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:
  • Meningeal involvement
  • Serious active infections
  • Serious underlying medical conditions
  • 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

August 1, 2002

Primary Completion

June 1, 2004

Study Completion

November 1, 2004

Last Updated

July 28, 2010

Record last verified: 2010-07