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

NCT ID: NCT00193388

Last Updated: 2010-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30
• Study Completion Date: 2007-02-28

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

Detailed Description

Upon determination of eligibility, all patients will be receive:

• Topotecan

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Topotecan

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Principal Investigators

Anthony Greco, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Other Identifiers

104864664

Identifier Type: -

Identifier Source: secondary_id

SCRI LUN 66

Identifier Type: -

Identifier Source: org_study_id