Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

Phase II Trial of Weekly Topotecan in the First-line Treatment of Elderly Patients With Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193401
• Other study ID #: SCRI LUN 65
• Secondary ID: 104864665
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 27, 2010
• Start date: August 2002
• Est. completion date: November 2004

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 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

Description:

Upon determination of eligibility, all patients will be receive:

• Topotecan

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2004
• Est. primary completion date: June 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:

• 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.

Exclusion Criteria:

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

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	Institutional Review Board TriStar Nashville Market

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate
Secondary	Median survival
Secondary	1 year and 2 year survival
Secondary	Overall toxicity