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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: Topotecan

Study type

Interventional

Funder types

Other

Identifiers

NCT00193401

SCRI LUN 65

104864665

Details and patient eligibility

About

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

Full description

Upon determination of eligibility, all patients will be receive:

Topotecan

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.