Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Non-Small Cell Lung Cancer in Elderly Patients

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Lung Cancer

Treatments

Drug: Docetaxel

Drug: Gemcitabine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193323

SCRI LUN 52

104864-450

Details and patient eligibility

About

In this randomized trial, we attempt to further define optimal palliative chemotherapy for elderly patients with advanced non-small cell lung cancer by comparing single agent treatment with weekly docetaxel versus combination therapy with weekly docetaxel plus gemcitabine.

Full description

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

Docetaxel Docetaxel + Gemcitabine

For ever 2 patients treated, 1 will receive treatment A (docetaxel) and 1 will receive treatment B (Docetaxel + Gemcitabine). 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

Accepts Healthy Volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria:

Biopsy-proven non-small cell lung cancer
No previous chemotherapy.
Age > 65 years
Age < 65 years requires significant assistance to perform activities of daily
Stage IV disease or stage IIIB disease
Ability to perform activities of daily living with minimal assistance
Measurable or evaluable disease
Adequate bone marrow, liver and kidney
All patients must sign written informed consent prior to study entry.

Exclusion criteria

You cannot participate in this study if any of the following apply to you:

Brain metastases
Meningeal metastases
Other uncontrolled malignancies
History of invasive cancer during the last 5 years
Moderate to severe 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.