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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

346 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer

NCT01652820

Non Small-cell Lung Cancer

COMPLETED PHASE2

Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer

NCT00148291

Lung Cancer

COMPLETED PHASE3

Comparison of IV Topotecan/Docetaxel to Docetaxel Alone in Second-Line Stage IIIB/IV Non-Small Cell Lung Cancer

NCT00065182

Lung Cancer, Non-Small Cell Non-Small-Cell Lung Cancer

COMPLETED PHASE2

Randomized Trial of Docetaxel and Gemcitabine Versus Gemcitabine in Elderly Patients With NSCLC

NCT00442026

Non-small-cell Lung Cancer

TERMINATED PHASE3

Docetaxel or Pemetrexed With or Without Cetuximab in Patients With Recurrent or Progressive Non-Small Cell Lung Cancer

NCT00095199

Non Small Cell Lung Cancer

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel

Intervention Type DRUG

Gemcitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes