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

Lung Cancer Clinical Trial

Official title:

A Randomized Phase III Comparison of Weekly Docetaxel Versus Weekly Docetaxel/Gemcitabine in the Treatment of Elderly or Poor Performance Status Patients With Advanced Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193323
• Other study ID #: SCRI LUN 52
• Secondary ID: 104864-450
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: June 24, 2010
• Start date: August 2001
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 346
• Est. completion date: January 2009
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Docetaxel

• Gemcitabine

Locations

Country	Name	City	State
United States	Tennessee Oncology, PLLC	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hainsworth JD, Spigel DR, Farley C, Shipley DL, Bearden JD, Gandhi J, Ann Houston G, Anthony Greco F. Weekly docetaxel versus docetaxel/gemcitabine in the treatment of elderly or poor performance status patients with advanced nonsmall cell lung cancer: a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	median survival
Primary	one-year survival.
Secondary	toxicity

External Links

•   Published article in Cancer