A Randomized Trial of Oral Topotecan Versus Docetaxel in Second-Line Treatment of Non-Small Cell Lung Cancer

SCRI Development Innovations, LLC1 site in 1 country80 target enrollmentNovember 2000

ConditionsLung Cancer

DrugsTopotecan Docetaxel

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Lung Cancer
Sponsor: SCRI Development Innovations, LLC
Enrollment: 80
Locations: 1
Primary Endpoint: Overall response rate
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

In this trial we will evaluate and compare the efficacy and toxicity of oral topotecan with intravenous docetaxel in the second-line treatment of patients with non-small cell lung cancer.

Detailed Description

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Topotecan * Docetaxel For ever 2 patients treated, 1 will receive treatment A (Topotecan) and 1 will receive treatment B (Docetaxel). The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Registry

clinicaltrials.gov

Start Date

November 2000

End Date

January 2009

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

SCRI Development Innovations, LLC

Eligibility Criteria

Inclusion Criteria

•To be included in this study, you must meet the following criteria:
•Relapsed or Progressive Disease
•Stage IIIB (not candidate for combined modality) or IV
•No more than one prior chemotherapy regimen
•Able to perform activities of daily living without assistance
•Measurable disease outside of radiation port
•Adequate bone marrow, liver and kidney function
•Must understand study and sign informed consent prior to enrollment

Exclusion Criteria

•You cannot participate in this study if any of the following apply to you:
•Prior treatment with Topotecan or Docetaxel
•Uncontrolled brain metastases
•Moderate peripheral neuropathy
•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.