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

Phase 2

Completed

• Conditions: Lung Cancer

• Registration Number: NCT00193323
• Lead Sponsor: SCRI Development Innovations, LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2006-05
• Status Verified: 2009-01
• Study Completion: 2009-01
• Last Update Submitted: 2010-06-24
• Last Update Posted: 2010-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
median survival
one-year survival.

Secondary Outcome Measures

Name	Time	Method
toxicity

Trial Locations

Locations (1)

Tennessee Oncology, PLLC; 🇺🇸 Nashville, Tennessee, United States