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Weekly Topotecan in the First...

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

NCT ID: NCT00193401

Last Updated: 2010-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2004-11-30

Brief Summary

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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

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Detailed Description

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Upon determination of eligibility, all patients will be receive:

* Topotecan

Conditions

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Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Topotecan

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers