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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00193388
Enrollment
100
Registered
2005-09-19
Start date
2002-09-30
Completion date
2007-02-28
Last updated
2010-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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

Interventions

DRUGTopotecan

Sponsors

GlaxoSmithKline
CollaboratorINDUSTRY
SCRI Development Innovations, LLC
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frame
Overall response rate

Secondary

MeasureTime frame
Median survival
1-year survival
Symptomatic improvement

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026