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

SCRI Development Innovations, LLC0 sites40 target enrollmentAugust 2002

ConditionsLung Cancer

DrugsTopotecan

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: SCRI Development Innovations, LLC
Enrollment: 40
Primary Endpoint: Overall response rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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

Detailed Description

Upon determination of eligibility, all patients will be receive: * Topotecan

Registry

clinicaltrials.gov

Start Date

August 2002

End Date

November 2004

Last Updated

15 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

SCRI Development Innovations, LLC

Eligibility 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.