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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: Topotecan

Drug: Docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193245

SCRI LUN 47

104864-450

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.