Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Weekly Topotecan in the Second-Line Treatment of Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193388
• Other study ID #: SCRI LUN 66
• Secondary ID: 104864664
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 27, 2010
• Start date: September 2002
• Est. completion date: February 2007

Study information

• Verified date: July 2010
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

Upon determination of eligibility, all patients will be receive:

• Topotecan

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2007
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Topotecan

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Median survival
Secondary	1-year survival
Secondary	Symptomatic improvement