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

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

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

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Topotecan

Detailed Description

Upon determination of eligibility, all patients will be receive:

• Topotecan

• Study Type: Interventional
• Enrollment: 100
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate

Secondary Outcome Measures

Outcome Measure
Median survival
Symptomatic improvement
1-year survival

Collaborators and Investigators

• Sponsor: SCRI Development Innovations, LLC
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): December 1, 2004
• Study Completion: February 1, 2007

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Estimate): July 28, 2010
• Last Update Submitted That Met QC Criteria: July 27, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Topotecan
• Other Study ID Numbers: SCRI LUN 66; 104864664