Overview

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

Status:
Completed
Trial end date:
2004-11-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborator:
Institutional Review Board TriStar Nashville Market
Treatments:
Topotecan
Criteria
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.